phpinfo()
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PHP Version 5.6.40

System Windows NT iZ4r4b31413jd2Z 10.0 build 14393 (Windows Server 2016) AMD64
Build Date Jan 9 2019 15:05:36
Compiler MSVC11 (Visual C++ 2012)
Architecture x64
Configure Command cscript /nologo configure.js "--enable-snapshot-build" "--enable-debug-pack" "--disable-zts" "--disable-isapi" "--disable-nsapi" "--without-mssql" "--without-pdo-mssql" "--without-pi3web" "--with-pdo-oci=c:\php-sdk\oracle\x64\instantclient_12_1\sdk,shared" "--with-oci8-12c=c:\php-sdk\oracle\x64\instantclient_12_1\sdk,shared" "--with-enchant=shared" "--enable-object-out-dir=../obj/" "--enable-com-dotnet=shared" "--with-mcrypt=static" "--without-analyzer" "--with-pgo"
Server API CGI/FastCGI
Virtual Directory Support disabled
Configuration File (php.ini) Path C:\Windows
Loaded Configuration File D:\PHPWEB\php\php.ini
Scan this dir for additional .ini files (none)
Additional .ini files parsed (none)
PHP API 20131106
PHP Extension 20131226
Zend Extension 220131226
Zend Extension Build API220131226,NTS,VC11
PHP Extension Build API20131226,NTS,VC11
Debug Build no
Thread Safety disabled
Zend Signal Handling disabled
Zend Memory Manager enabled
Zend Multibyte Support provided by mbstring
IPv6 Support enabled
DTrace Support disabled
Registered PHP Streamsphp, file, glob, data, http, ftp, zip, compress.zlib, compress.bzip2, https, ftps, phar
Registered Stream Socket Transportstcp, udp, ssl, sslv3, tls, tlsv1.0, tlsv1.1, tlsv1.2
Registered Stream Filtersconvert.iconv.*, mcrypt.*, mdecrypt.*, string.rot13, string.toupper, string.tolower, string.strip_tags, convert.*, consumed, dechunk, zlib.*, bzip2.*
Zend logo This program makes use of the Zend Scripting Language Engine:
Zend Engine v2.6.0, Copyright (c) 1998-2016 Zend Technologies

Configuration

bcmath

BCMath support enabled
DirectiveLocal ValueMaster Value
bcmath.scale00

bz2

BZip2 Support Enabled
Stream Wrapper support compress.bzip2://
Stream Filter support bzip2.decompress, bzip2.compress
BZip2 Version 1.0.6, 6-Sept-2010

calendar

Calendar support enabled

cgi-fcgi

DirectiveLocal ValueMaster Value
cgi.check_shebang_line11
cgi.discard_path00
cgi.fix_pathinfo11
cgi.force_redirect00
cgi.nph00
cgi.redirect_status_envno valueno value
cgi.rfc2616_headers00
fastcgi.impersonate11
fastcgi.logging11

Core

PHP Version 5.6.40
DirectiveLocal ValueMaster Value
allow_url_fopenOnOn
allow_url_includeOffOff
always_populate_raw_post_data00
arg_separator.input&&
arg_separator.output&&
asp_tagsOffOff
auto_append_fileno valueno value
auto_globals_jitOnOn
auto_prepend_fileno valueno value
browscapno valueno value
default_charsetUTF-8UTF-8
default_mimetypetext/htmltext/html
disable_classesno valueno value
disable_functionsexec,system,passthru,popen,pclose,shell_exec,proc_open,dl,chmodexec,system,passthru,popen,pclose,shell_exec,proc_open,dl,chmod
display_errorsOffOff
display_startup_errorsOffOff
doc_rootno valueno value
docref_extno valueno value
docref_rootno valueno value
enable_dlOffOff
enable_post_data_readingOnOn
error_append_stringno valueno value
error_logsyslogsyslog
error_prepend_stringno valueno value
error_reporting022527
exit_on_timeoutOffOff
expose_phpOnOn
extension_dir./ext./ext
file_uploadsOnOn
highlight.comment#FF8000#FF8000
highlight.default#0000BB#0000BB
highlight.html#000000#000000
highlight.keyword#007700#007700
highlight.string#DD0000#DD0000
html_errorsOnOn
ignore_repeated_errorsOffOff
ignore_repeated_sourceOffOff
ignore_user_abortOffOff
implicit_flushOffOff
include_path.;C:\php\pear;D:\wwwroot\yyjg.net\wwwroot\core/Extend/Vendor/.;C:\php\pear
input_encodingno valueno value
internal_encodingno valueno value
log_errorsOnOn
log_errors_max_len10241024
mail.add_x_headerOnOn
mail.force_extra_parametersno valueno value
mail.logno valueno value
max_execution_time180180
max_file_uploads200200
max_input_nesting_level6464
max_input_time6060
max_input_vars10001000
memory_limit128M128M
open_basedirno valueno value
output_buffering40964096
output_encodingno valueno value
output_handlerno valueno value
post_max_size200M200M
precision1414
realpath_cache_size16K16K
realpath_cache_ttl120120
register_argc_argvOffOff
report_memleaksOnOn
report_zend_debugOnOn
request_orderCGPCGP
sendmail_fromno valueno value
sendmail_pathno valueno value
serialize_precision1717
short_open_tagOnOn
SMTPlocalhostlocalhost
smtp_port2525
sql.safe_modeOffOff
sys_temp_dirno valueno value
track_errorsOffOff
unserialize_callback_funcno valueno value
upload_max_filesize200M200M
upload_tmp_dirD:\PHPWEB\php\temp\D:\PHPWEB\php\temp\
user_dirno valueno value
user_ini.cache_ttl300300
user_ini.filename.user.ini.user.ini
variables_orderGPCSGPCS
windows.show_crt_warningOffOff
xmlrpc_error_number00
xmlrpc_errorsOffOff
zend.detect_unicodeOnOn
zend.enable_gcOnOn
zend.multibyteOffOff
zend.script_encodingno valueno value

ctype

ctype functions enabled

curl

cURL support enabled
cURL Information 7.59.0
Age 4
Features
AsynchDNS Yes
CharConv No
Debug No
GSS-Negotiate No
IDN Yes
IPv6 Yes
krb4 No
Largefile Yes
libz Yes
NTLM Yes
NTLMWB No
SPNEGO Yes
SSL Yes
SSPI Yes
TLS-SRP No
Protocols dict, file, ftp, ftps, gopher, http, https, imap, imaps, ldap, pop3, pop3s, rtsp, scp, sftp, smb, smbs, smtp, smtps, telnet, tftp
Host x86_64-pc-win32
SSL Version OpenSSL/1.0.2q
ZLib Version 1.2.7.3
libSSH Version libssh2/1.8.0

date

date/time support enabled
"Olson" Timezone Database Version 2016.10
Timezone Database internal
Default timezone PRC
DirectiveLocal ValueMaster Value
date.default_latitude31.766731.7667
date.default_longitude35.233335.2333
date.sunrise_zenith90.58333390.583333
date.sunset_zenith90.58333390.583333
date.timezonePRCPRC

dom

DOM/XML enabled
DOM/XML API Version 20031129
libxml Version 2.9.4
HTML Support enabled
XPath Support enabled
XPointer Support enabled
Schema Support enabled
RelaxNG Support enabled

ereg

Regex Library Bundled library enabled

exif

EXIF Support enabled
EXIF Version 1.4 $Id: cad29b729548e4206f0697710cc9e177f26fdff3 $
Supported EXIF Version 0220
Supported filetypes JPEG,TIFF
DirectiveLocal ValueMaster Value
exif.decode_jis_intelJISJIS
exif.decode_jis_motorolaJISJIS
exif.decode_unicode_intelUCS-2LEUCS-2LE
exif.decode_unicode_motorolaUCS-2BEUCS-2BE
exif.encode_jisno valueno value
exif.encode_unicodeISO-8859-15ISO-8859-15

filter

Input Validation and Filtering enabled
Revision $Id: 5b79667bd9a68977a9b4f7505223a8e216e04908 $
DirectiveLocal ValueMaster Value
filter.defaultunsafe_rawunsafe_raw
filter.default_flagsno valueno value

ftp

FTP support enabled

gd

GD Support enabled
GD Version bundled (2.1.0 compatible)
FreeType Support enabled
FreeType Linkage with freetype
FreeType Version 2.7.0
GIF Read Support enabled
GIF Create Support enabled
JPEG Support enabled
libJPEG Version 9 compatible
PNG Support enabled
libPNG Version 1.5.26
WBMP Support enabled
XPM Support enabled
libXpm Version 30512
XBM Support enabled
WebP Support enabled
DirectiveLocal ValueMaster Value
gd.jpeg_ignore_warning00

hash

hash support enabled
Hashing Engines md2 md4 md5 sha1 sha224 sha256 sha384 sha512 ripemd128 ripemd160 ripemd256 ripemd320 whirlpool tiger128,3 tiger160,3 tiger192,3 tiger128,4 tiger160,4 tiger192,4 snefru snefru256 gost gost-crypto adler32 crc32 crc32b fnv132 fnv1a32 fnv164 fnv1a64 joaat haval128,3 haval160,3 haval192,3 haval224,3 haval256,3 haval128,4 haval160,4 haval192,4 haval224,4 haval256,4 haval128,5 haval160,5 haval192,5 haval224,5 haval256,5

iconv

iconv support enabled
iconv implementation "libiconv"
iconv library version 1.14
DirectiveLocal ValueMaster Value
iconv.input_encodingno valueno value
iconv.internal_encodingno valueno value
iconv.output_encodingno valueno value

json

json support enabled
json version 1.2.1

libxml

libXML support active
libXML Compiled Version 2.9.4
libXML Loaded Version 20904
libXML streams enabled

mbstring

Multibyte Support enabled
Multibyte string engine libmbfl
HTTP input encoding translation disabled
libmbfl version 1.3.2
mbstring extension makes use of "streamable kanji code filter and converter", which is distributed under the GNU Lesser General Public License version 2.1.
Multibyte (japanese) regex support enabled
Multibyte regex (oniguruma) version 5.9.5
DirectiveLocal ValueMaster Value
mbstring.detect_orderno valueno value
mbstring.encoding_translationOffOff
mbstring.func_overload00
mbstring.http_inputno valueno value
mbstring.http_outputno valueno value
mbstring.http_output_conv_mimetypes^(text/|application/xhtml\+xml)^(text/|application/xhtml\+xml)
mbstring.internal_encodingno valueno value
mbstring.languageneutralneutral
mbstring.strict_detectionOffOff
mbstring.substitute_characterno valueno value

mcrypt

mcrypt supportenabled
mcrypt_filter supportenabled
Version 2.5.8
Api No 20021217
Supported ciphers cast-128 gost rijndael-128 twofish cast-256 loki97 rijndael-192 saferplus wake blowfish-compat des rijndael-256 serpent xtea blowfish enigma rc2 tripledes arcfour
Supported modes cbc cfb ctr ecb ncfb nofb ofb stream
DirectiveLocal ValueMaster Value
mcrypt.algorithms_dirno valueno value
mcrypt.modes_dirno valueno value

mhash

MHASH support Enabled
MHASH API Version Emulated Support

mysql

MySQL Supportenabled
Active Persistent Links 0
Active Links 1
Client API version mysqlnd 5.0.11-dev - 20120503 - $Id: 76b08b24596e12d4553bd41fc93cccd5bac2fe7a $
DirectiveLocal ValueMaster Value
mysql.allow_local_infileOnOn
mysql.allow_persistentOnOn
mysql.connect_timeout6060
mysql.default_hostno valueno value
mysql.default_passwordno valueno value
mysql.default_portno valueno value
mysql.default_socketno valueno value
mysql.default_userno valueno value
mysql.max_linksUnlimitedUnlimited
mysql.max_persistentUnlimitedUnlimited
mysql.trace_modeOffOff

mysqli

MysqlI Supportenabled
Client API library version mysqlnd 5.0.11-dev - 20120503 - $Id: 76b08b24596e12d4553bd41fc93cccd5bac2fe7a $
Active Persistent Links 0
Inactive Persistent Links 0
Active Links 0
DirectiveLocal ValueMaster Value
mysqli.allow_local_infileOnOn
mysqli.allow_persistentOnOn
mysqli.default_hostno valueno value
mysqli.default_port33063306
mysqli.default_pwno valueno value
mysqli.default_socketno valueno value
mysqli.default_userno valueno value
mysqli.max_linksUnlimitedUnlimited
mysqli.max_persistentUnlimitedUnlimited
mysqli.reconnectOffOff
mysqli.rollback_on_cached_plinkOffOff

mysqlnd

mysqlndenabled
Version mysqlnd 5.0.11-dev - 20120503 - $Id: 76b08b24596e12d4553bd41fc93cccd5bac2fe7a $
Compression supported
core SSL supported
extended SSL not supported
Command buffer size 4096
Read buffer size 32768
Read timeout 31536000
Collecting statistics Yes
Collecting memory statistics No
Tracing n/a
Loaded plugins mysqlnd,debug_trace,auth_plugin_mysql_native_password,auth_plugin_mysql_clear_password
API Extensions mysql,mysqli,pdo_mysql
mysqlnd statistics
bytes_sent 337465
bytes_received 7634357
packets_sent 7264
packets_received 65685
protocol_overhead_in 262740
protocol_overhead_out 29056
bytes_received_ok_packet 0
bytes_received_eof_packet 0
bytes_received_rset_header_packet 28026
bytes_received_rset_field_meta_packet 0
bytes_received_rset_row_packet 20732
bytes_received_prepare_response_packet 2874100
bytes_received_change_user_packet 4685347
packets_sent_command 3484
packets_received_ok 0
packets_received_eof 0
packets_received_rset_header 3114
packets_received_rset_field_meta 0
packets_received_rset_row 3263
packets_received_prepare_response 41617
packets_received_change_user 17395
result_set_queries 3040
non_result_set_queries 221
no_index_used 2010
bad_index_used 0
slow_queries 0
buffered_sets 3040
unbuffered_sets 0
ps_buffered_sets 0
ps_unbuffered_sets 0
flushed_normal_sets 0
flushed_ps_sets 0
ps_prepared_never_executed 0
ps_prepared_once_executed 0
rows_fetched_from_server_normal 14355
rows_fetched_from_server_ps 0
rows_buffered_from_client_normal 14355
rows_buffered_from_client_ps 0
rows_fetched_from_client_normal_buffered 14355
rows_fetched_from_client_normal_unbuffered 0
rows_fetched_from_client_ps_buffered 0
rows_fetched_from_client_ps_unbuffered 0
rows_fetched_from_client_ps_cursor 0
rows_affected_normal 63
rows_affected_ps 0
rows_skipped_normal 14355
rows_skipped_ps 0
copy_on_write_saved 83023
copy_on_write_performed 112549
command_buffer_too_small 0
connect_success 74
connect_failure 0
connection_reused 0
reconnect 0
pconnect_success 0
active_connections 18446744073709551544
active_persistent_connections 0
explicit_close 73
implicit_close 0
disconnect_close 0
in_middle_of_command_close 0
explicit_free_result 3039
implicit_free_result 0
explicit_stmt_close 0
implicit_stmt_close 0
mem_emalloc_count 0
mem_emalloc_amount 0
mem_ecalloc_count 0
mem_ecalloc_amount 0
mem_erealloc_count 0
mem_erealloc_amount 0
mem_efree_count 0
mem_efree_amount 0
mem_malloc_count 0
mem_malloc_amount 0
mem_calloc_count 0
mem_calloc_amount 0
mem_realloc_count 0
mem_realloc_amount 0
mem_free_count 0
mem_free_amount 0
mem_estrndup_count 0
mem_strndup_count 0
mem_estndup_count 0
mem_strdup_count 0
proto_text_fetched_null 0
proto_text_fetched_bit 0
proto_text_fetched_tinyint 13658
proto_text_fetched_short 47648
proto_text_fetched_int24 3933
proto_text_fetched_int 4328
proto_text_fetched_bigint 15
proto_text_fetched_decimal 0
proto_text_fetched_float 0
proto_text_fetched_double 0
proto_text_fetched_date 0
proto_text_fetched_year 0
proto_text_fetched_time 0
proto_text_fetched_datetime 0
proto_text_fetched_timestamp 0
proto_text_fetched_string 102325
proto_text_fetched_blob 0
proto_text_fetched_enum 10082
proto_text_fetched_set 0
proto_text_fetched_geometry 0
proto_text_fetched_other 0
proto_binary_fetched_null 0
proto_binary_fetched_bit 0
proto_binary_fetched_tinyint 0
proto_binary_fetched_short 0
proto_binary_fetched_int24 0
proto_binary_fetched_int 0
proto_binary_fetched_bigint 0
proto_binary_fetched_decimal 0
proto_binary_fetched_float 0
proto_binary_fetched_double 0
proto_binary_fetched_date 0
proto_binary_fetched_year 0
proto_binary_fetched_time 0
proto_binary_fetched_datetime 0
proto_binary_fetched_timestamp 0
proto_binary_fetched_string 0
proto_binary_fetched_json 0
proto_binary_fetched_blob 0
proto_binary_fetched_enum 0
proto_binary_fetched_set 0
proto_binary_fetched_geometry 0
proto_binary_fetched_other 0
init_command_executed_count 0
init_command_failed_count 0
com_quit 73
com_init_db 74
com_query 3263
com_field_list 0
com_create_db 0
com_drop_db 0
com_refresh 0
com_shutdown 0
com_statistics 0
com_process_info 0
com_connect 0
com_process_kill 0
com_debug 0
com_ping 0
com_time 0
com_delayed_insert 0
com_change_user 0
com_binlog_dump 0
com_table_dump 0
com_connect_out 0
com_register_slave 0
com_stmt_prepare 0
com_stmt_execute 0
com_stmt_send_long_data 0
com_stmt_close 0
com_stmt_reset 0
com_stmt_set_option 74
com_stmt_fetch 0
com_deamon 0
bytes_received_real_data_normal 4418485
bytes_received_real_data_ps 0

odbc

ODBC Supportenabled
Active Persistent Links 0
Active Links 0
ODBC library Win32
DirectiveLocal ValueMaster Value
odbc.allow_persistentOnOn
odbc.check_persistentOnOn
odbc.default_cursortypeStatic cursorStatic cursor
odbc.default_dbno valueno value
odbc.default_pwno valueno value
odbc.default_userno valueno value
odbc.defaultbinmodereturn as isreturn as is
odbc.defaultlrlreturn up to 4096 bytesreturn up to 4096 bytes
odbc.max_linksUnlimitedUnlimited
odbc.max_persistentUnlimitedUnlimited

openssl

OpenSSL support enabled
OpenSSL Library Version OpenSSL 1.0.2q 20 Nov 2018
OpenSSL Header Version OpenSSL 1.0.2q 20 Nov 2018
Openssl default config c:/usr/local/ssl/openssl.cnf
DirectiveLocal ValueMaster Value
openssl.cafileno valueno value
openssl.capathno valueno value

pcre

PCRE (Perl Compatible Regular Expressions) Support enabled
PCRE Library Version 8.38 2015-11-23
DirectiveLocal ValueMaster Value
pcre.backtrack_limit10000001000000
pcre.recursion_limit100000100000

PDO

PDO supportenabled
PDO drivers mysql, odbc, pgsql, sqlite

pdo_mysql

PDO Driver for MySQLenabled
Client API version mysqlnd 5.0.11-dev - 20120503 - $Id: 76b08b24596e12d4553bd41fc93cccd5bac2fe7a $

PDO_ODBC

PDO Driver for ODBC (Win32)enabled
ODBC Connection Pooling Enabled, strict matching

pdo_pgsql

PDO Driver for PostgreSQLenabled
PostgreSQL(libpq) Version 9.6.2
Module version 1.0.2
Revision $Id: 0e858dd2051ca8c2fd3c781909a0670ab5fecd36 $

pdo_sqlite

PDO Driver for SQLite 3.xenabled
SQLite Library 3.8.10.2

pgsql

PostgreSQL Supportenabled
PostgreSQL(libpq) Version 9.6.2
PostgreSQL(libpq) PostgreSQL 9.6.2 (win32)
Multibyte character support enabled
SSL support enabled
Active Persistent Links 0
Active Links 0
DirectiveLocal ValueMaster Value
pgsql.allow_persistentOnOn
pgsql.auto_reset_persistentOffOff
pgsql.ignore_noticeOffOff
pgsql.log_noticeOffOff
pgsql.max_linksUnlimitedUnlimited
pgsql.max_persistentUnlimitedUnlimited

Phar

Phar: PHP Archive supportenabled
Phar EXT version 2.0.2
Phar API version 1.1.1
SVN revision $Id: 6e5cec2462a6ded53d4379ea9a69487a60d5c43c $
Phar-based phar archives enabled
Tar-based phar archives enabled
ZIP-based phar archives enabled
gzip compression enabled
bzip2 compression enabled
OpenSSL support enabled
Phar based on pear/PHP_Archive, original concept by Davey Shafik.
Phar fully realized by Gregory Beaver and Marcus Boerger.
Portions of tar implementation Copyright (c) 2003-2009 Tim Kientzle.
DirectiveLocal ValueMaster Value
phar.cache_listno valueno value
phar.readonlyOnOn
phar.require_hashOnOn

Reflection

Reflectionenabled
Version $Id: 5f15287237d5f78d75b19c26915aa7bd83dee8b8 $

session

Session Support enabled
Registered save handlers files user
Registered serializer handlers php_serialize php php_binary wddx
DirectiveLocal ValueMaster Value
session.auto_startOffOff
session.cache_expire180180
session.cache_limiternocachenocache
session.cookie_domainno valueno value
session.cookie_httponlyOffOff
session.cookie_lifetime00
session.cookie_path//
session.cookie_secureOffOff
session.entropy_fileno valueno value
session.entropy_length00
session.gc_divisor10001000
session.gc_maxlifetime14401440
session.gc_probability11
session.hash_bits_per_character55
session.hash_function00
session.namePHPSESSIDPHPSESSID
session.referer_checkno valueno value
session.save_handlerfilesfiles
session.save_pathD:\PHPWEB\php\temp\D:\PHPWEB\php\temp\
session.serialize_handlerphpphp
session.upload_progress.cleanupOnOn
session.upload_progress.enabledOnOn
session.upload_progress.freq1%1%
session.upload_progress.min_freq11
session.upload_progress.namePHP_SESSION_UPLOAD_PROGRESSPHP_SESSION_UPLOAD_PROGRESS
session.upload_progress.prefixupload_progress_upload_progress_
session.use_cookiesOnOn
session.use_only_cookiesOnOn
session.use_strict_modeOffOff
session.use_trans_sid00

SimpleXML

Simplexml supportenabled
Revision $Id: d7077fc935154236afb4fe70814ba358efdbdca4 $
Schema support enabled

SPL

SPL supportenabled
Interfaces Countable, OuterIterator, RecursiveIterator, SeekableIterator, SplObserver, SplSubject
Classes AppendIterator, ArrayIterator, ArrayObject, BadFunctionCallException, BadMethodCallException, CachingIterator, CallbackFilterIterator, DirectoryIterator, DomainException, EmptyIterator, FilesystemIterator, FilterIterator, GlobIterator, InfiniteIterator, InvalidArgumentException, IteratorIterator, LengthException, LimitIterator, LogicException, MultipleIterator, NoRewindIterator, OutOfBoundsException, OutOfRangeException, OverflowException, ParentIterator, RangeException, RecursiveArrayIterator, RecursiveCachingIterator, RecursiveCallbackFilterIterator, RecursiveDirectoryIterator, RecursiveFilterIterator, RecursiveIteratorIterator, RecursiveRegexIterator, RecursiveTreeIterator, RegexIterator, RuntimeException, SplDoublyLinkedList, SplFileInfo, SplFileObject, SplFixedArray, SplHeap, SplMinHeap, SplMaxHeap, SplObjectStorage, SplPriorityQueue, SplQueue, SplStack, SplTempFileObject, UnderflowException, UnexpectedValueException

sqlite3

SQLite3 supportenabled
SQLite3 module version 0.7-dev
SQLite Library 3.8.10.2
DirectiveLocal ValueMaster Value
sqlite3.extension_dirno valueno value

standard

Dynamic Library Support enabled
Internal Sendmail Support for Windows enabled
DirectiveLocal ValueMaster Value
assert.active11
assert.bail00
assert.callbackno valueno value
assert.quiet_eval00
assert.warning11
auto_detect_line_endings00
default_socket_timeout6060
fromno valueno value
url_rewriter.tagsa=href,area=href,frame=src,input=src,form=fakeentrya=href,area=href,frame=src,input=src,form=fakeentry
user_agentno valueno value

tokenizer

Tokenizer Support enabled

wddx

WDDX Supportenabled
WDDX Session Serializer enabled

xml

XML Support active
XML Namespace Support active
libxml2 Version 2.9.4

xmlreader

XMLReader enabled

xmlwriter

XMLWriter enabled

zip

Zip enabled
Zip version 1.12.5
Libzip version 0.11.2

zlib

ZLib Supportenabled
Stream Wrapper compress.zlib://
Stream Filter zlib.inflate, zlib.deflate
Compiled Version 1.2.7.3
Linked Version 1.2.7.3
DirectiveLocal ValueMaster Value
zlib.output_compressionOffOff
zlib.output_compression_level-1-1
zlib.output_handlerno valueno value

Additional Modules

Module Name

Environment

VariableValue
_FCGI_X_PIPE_ \\.\pipe\IISFCGI-46af6d28-9370-4a80-8f84-1be81149db30
PHP_FCGI_MAX_REQUESTS 10000
ALLUSERSPROFILE C:\ProgramData
APPDATA C:\Windows\system32\config\systemprofile\AppData\Roaming
APP_POOL_CONFIG C:\inetpub\temp\apppools\wwwroot\wwwroot.config
APP_POOL_ID wwwroot
CommonProgramFiles C:\Program Files\Common Files
CommonProgramFiles(x86) C:\Program Files (x86)\Common Files
CommonProgramW6432 C:\Program Files\Common Files
COMPUTERNAME iZ4r4b31413jd2Z
ComSpec C:\Windows\system32\cmd.exe
LOCALAPPDATA C:\Windows\system32\config\systemprofile\AppData\Local
NUMBER_OF_PROCESSORS 2
OS Windows_NT
Path C:\Windows\system32;C:\Windows;C:\Windows\System32\Wbem;C:\Windows\System32\WindowsPowerShell\v1.0\;D:\Program Files\Microsoft SQL Server\110\DTS\Binn\;D:\Program Files (x86)\Microsoft SQL Server\110\Tools\Binn\;D:\Program Files\Microsoft SQL Server\110\Tools\Binn\;D:\Program Files (x86)\Microsoft SQL Server\110\Tools\Binn\ManagementStudio\;C:\Program Files (x86)\Microsoft Visual Studio 10.0\Common7\IDE\PrivateAssemblies\;D:\Program Files (x86)\Microsoft SQL Server\110\DTS\Binn\;C:\sslctlw;C:\Windows\system32\config\systemprofile\AppData\Local\Microsoft\WindowsApps
PATHEXT .COM;.EXE;.BAT;.CMD;.VBS;.VBE;.JS;.JSE;.WSF;.WSH;.MSC
PROCESSOR_ARCHITECTURE AMD64
PROCESSOR_IDENTIFIER Intel64 Family 6 Model 85 Stepping 4, GenuineIntel
PROCESSOR_LEVEL 6
PROCESSOR_REVISION 5504
ProgramData C:\ProgramData
ProgramFiles C:\Program Files
ProgramFiles(x86) C:\Program Files (x86)
ProgramW6432 C:\Program Files
PSModulePath C:\Program Files\WindowsPowerShell\Modules;C:\Windows\system32\WindowsPowerShell\v1.0\Modules;D:\Program Files (x86)\Microsoft SQL Server\110\Tools\PowerShell\Modules\
PUBLIC C:\Users\Public
SystemDrive C:
SystemRoot C:\Windows
TEMP C:\Windows\TEMP
TMP C:\Windows\TEMP
USERDOMAIN WORKGROUP
USERNAME iZ4r4b31413jd2Z$
USERPROFILE C:\Windows\system32\config\systemprofile
windir C:\Windows

PHP Variables

VariableValue
_REQUEST["aid"]12548
_REQUEST["_URL_"]
Array
(
    [0] => index
    [1] => view
    [2] => aid
    [3] => 12548
)
_GET["aid"]12548
_GET["_URL_"]
Array
(
    [0] => index
    [1] => view
    [2] => aid
    [3] => 12548
)
_SERVER["_FCGI_X_PIPE_"]\\.\pipe\IISFCGI-46af6d28-9370-4a80-8f84-1be81149db30
_SERVER["PHP_FCGI_MAX_REQUESTS"]10000
_SERVER["ALLUSERSPROFILE"]C:\ProgramData
_SERVER["APPDATA"]C:\Windows\system32\config\systemprofile\AppData\Roaming
_SERVER["APP_POOL_CONFIG"]C:\inetpub\temp\apppools\wwwroot\wwwroot.config
_SERVER["APP_POOL_ID"]wwwroot
_SERVER["CommonProgramFiles"]C:\Program Files\Common Files
_SERVER["CommonProgramFiles(x86)"]C:\Program Files (x86)\Common Files
_SERVER["CommonProgramW6432"]C:\Program Files\Common Files
_SERVER["COMPUTERNAME"]iZ4r4b31413jd2Z
_SERVER["ComSpec"]C:\Windows\system32\cmd.exe
_SERVER["LOCALAPPDATA"]C:\Windows\system32\config\systemprofile\AppData\Local
_SERVER["NUMBER_OF_PROCESSORS"]2
_SERVER["OS"]Windows_NT
_SERVER["Path"]C:\Windows\system32;C:\Windows;C:\Windows\System32\Wbem;C:\Windows\System32\WindowsPowerShell\v1.0\;D:\Program Files\Microsoft SQL Server\110\DTS\Binn\;D:\Program Files (x86)\Microsoft SQL Server\110\Tools\Binn\;D:\Program Files\Microsoft SQL Server\110\Tools\Binn\;D:\Program Files (x86)\Microsoft SQL Server\110\Tools\Binn\ManagementStudio\;C:\Program Files (x86)\Microsoft Visual Studio 10.0\Common7\IDE\PrivateAssemblies\;D:\Program Files (x86)\Microsoft SQL Server\110\DTS\Binn\;C:\sslctlw;C:\Windows\system32\config\systemprofile\AppData\Local\Microsoft\WindowsApps
_SERVER["PATHEXT"].COM;.EXE;.BAT;.CMD;.VBS;.VBE;.JS;.JSE;.WSF;.WSH;.MSC
_SERVER["PROCESSOR_ARCHITECTURE"]AMD64
_SERVER["PROCESSOR_IDENTIFIER"]Intel64 Family 6 Model 85 Stepping 4, GenuineIntel
_SERVER["PROCESSOR_LEVEL"]6
_SERVER["PROCESSOR_REVISION"]5504
_SERVER["ProgramData"]C:\ProgramData
_SERVER["ProgramFiles"]C:\Program Files
_SERVER["ProgramFiles(x86)"]C:\Program Files (x86)
_SERVER["ProgramW6432"]C:\Program Files
_SERVER["PSModulePath"]C:\Program Files\WindowsPowerShell\Modules;C:\Windows\system32\WindowsPowerShell\v1.0\Modules;D:\Program Files (x86)\Microsoft SQL Server\110\Tools\PowerShell\Modules\
_SERVER["PUBLIC"]C:\Users\Public
_SERVER["SystemDrive"]C:
_SERVER["SystemRoot"]C:\Windows
_SERVER["TEMP"]C:\Windows\TEMP
_SERVER["TMP"]C:\Windows\TEMP
_SERVER["USERDOMAIN"]WORKGROUP
_SERVER["USERNAME"]iZ4r4b31413jd2Z$
_SERVER["USERPROFILE"]C:\Windows\system32\config\systemprofile
_SERVER["windir"]C:\Windows
_SERVER["ORIG_PATH_INFO"]/index.php/index-view-aid-12548.html
_SERVER["URL"]/index.php
_SERVER["SERVER_SOFTWARE"]Microsoft-IIS/10.0
_SERVER["SERVER_PROTOCOL"]HTTP/1.1
_SERVER["SERVER_PORT_SECURE"]1
_SERVER["SERVER_PORT"]443
_SERVER["SERVER_NAME"]www.yyjg.net
_SERVER["SCRIPT_NAME"]/index.php
_SERVER["SCRIPT_FILENAME"]D:\wwwroot\yyjg.net\wwwroot\index.php
_SERVER["REQUEST_URI"]/index.php/index-view-aid-12548.html
_SERVER["REQUEST_METHOD"]GET
_SERVER["REMOTE_USER"]no value
_SERVER["REMOTE_PORT"]60499
_SERVER["REMOTE_HOST"]216.73.216.32
_SERVER["REMOTE_ADDR"]216.73.216.32
_SERVER["QUERY_STRING"]no value
_SERVER["PATH_TRANSLATED"]D:\wwwroot\yyjg.net\wwwroot\index.php\index-view-aid-12548.html
_SERVER["PATH_INFO"]/index-view-aid-12548
_SERVER["LOGON_USER"]no value
_SERVER["LOCAL_ADDR"]172.16.121.93
_SERVER["INSTANCE_META_PATH"]/LM/W3SVC/1
_SERVER["INSTANCE_NAME"]WWWROOT
_SERVER["INSTANCE_ID"]1
_SERVER["HTTPS_SERVER_SUBJECT"]CN=www.yyjg.net
_SERVER["HTTPS_SERVER_ISSUER"]C=PL, O=Asseco Data Systems S.A., CN=Certum DV TLS G2 R39 CA
_SERVER["HTTPS_SECRETKEYSIZE"]2048
_SERVER["HTTPS_KEYSIZE"]256
_SERVER["HTTPS"]on
_SERVER["GATEWAY_INTERFACE"]CGI/1.1
_SERVER["DOCUMENT_ROOT"]D:\wwwroot\yyjg.net\wwwroot
_SERVER["CONTENT_TYPE"]no value
_SERVER["CONTENT_LENGTH"]0
_SERVER["CERT_SUBJECT"]no value
_SERVER["CERT_SERIALNUMBER"]no value
_SERVER["CERT_ISSUER"]no value
_SERVER["CERT_FLAGS"]no value
_SERVER["CERT_COOKIE"]no value
_SERVER["AUTH_USER"]no value
_SERVER["AUTH_PASSWORD"]no value
_SERVER["AUTH_TYPE"]no value
_SERVER["APPL_PHYSICAL_PATH"]D:\wwwroot\yyjg.net\wwwroot\
_SERVER["APPL_MD_PATH"]/LM/W3SVC/1/ROOT
_SERVER["IIS_UrlRewriteModule"]7.1.0871.0
_SERVER["HTTP_USER_AGENT"]Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)
_SERVER["HTTP_HOST"]www.yyjg.net
_SERVER["HTTP_ACCEPT_ENCODING"]gzip, br, zstd, deflate
_SERVER["HTTP_ACCEPT"]*/*
_SERVER["HTTP_CONNECTION"]close
_SERVER["FCGI_ROLE"]RESPONDER
_SERVER["PHP_SELF"]/index.php/index-view-aid-12548.html
_SERVER["REQUEST_TIME_FLOAT"]1789265428.0541
_SERVER["REQUEST_TIME"]1789265428

PHP Credits

PHP Group
Thies C. Arntzen, Stig Bakken, Shane Caraveo, Andi Gutmans, Rasmus Lerdorf, Sam Ruby, Sascha Schumann, Zeev Suraski, Jim Winstead, Andrei Zmievski
Language Design & Concept
Andi Gutmans, Rasmus Lerdorf, Zeev Suraski, Marcus Boerger
PHP Authors
ContributionAuthors
Zend Scripting Language Engine Andi Gutmans, Zeev Suraski, Stanislav Malyshev, Marcus Boerger, Dmitry Stogov, Xinchen Hui, Nikita Popov
Extension Module API Andi Gutmans, Zeev Suraski, Andrei Zmievski
UNIX Build and Modularization Stig Bakken, Sascha Schumann, Jani Taskinen
Windows Port Shane Caraveo, Zeev Suraski, Wez Furlong, Pierre-Alain Joye, Anatol Belski
Server API (SAPI) Abstraction Layer Andi Gutmans, Shane Caraveo, Zeev Suraski
Streams Abstraction Layer Wez Furlong, Sara Golemon
PHP Data Objects Layer Wez Furlong, Marcus Boerger, Sterling Hughes, George Schlossnagle, Ilia Alshanetsky
Output Handler Zeev Suraski, Thies C. Arntzen, Marcus Boerger, Michael Wallner
SAPI Modules
ContributionAuthors
AOLserver Sascha Schumann
Apache 1.3 (apache_hooks) Rasmus Lerdorf, Zeev Suraski, Stig Bakken, David Sklar, George Schlossnagle, Lukas Schroeder
Apache 1.3 Rasmus Lerdorf, Zeev Suraski, Stig Bakken, David Sklar
Apache 2.0 Filter Sascha Schumann, Aaron Bannert
Apache 2.0 Handler Ian Holsman, Justin Erenkrantz (based on Apache 2.0 Filter code)
Caudium / Roxen David Hedbor
CGI / FastCGI Rasmus Lerdorf, Stig Bakken, Shane Caraveo, Dmitry Stogov
CLI Edin Kadribasic, Marcus Boerger, Johannes Schlueter, Moriyoshi Koizumi, Xinchen Hui
Continuity Alex Leigh (based on nsapi code)
Embed Edin Kadribasic
FastCGI Process Manager Andrei Nigmatulin, dreamcat4, Antony Dovgal, Jerome Loyet
ISAPI Andi Gutmans, Zeev Suraski
litespeed George Wang
NSAPI Jayakumar Muthukumarasamy, Uwe Schindler
phpdbg Felipe Pena, Joe Watkins, Bob Weinand
phttpd Thies C. Arntzen
pi3web Holger Zimmermann
Sendmail Milter Harald Radi
thttpd Sascha Schumann
tux Sascha Schumann
WebJames Alex Waugh
Module Authors
ModuleAuthors
BC Math Andi Gutmans
Bzip2 Sterling Hughes
Calendar Shane Caraveo, Colin Viebrock, Hartmut Holzgraefe, Wez Furlong
COM and .Net Wez Furlong
ctype Hartmut Holzgraefe
cURL Sterling Hughes
Date/Time Support Derick Rethans
DB-LIB (MS SQL, Sybase) Wez Furlong, Frank M. Kromann
DBA Sascha Schumann, Marcus Boerger
DOM Christian Stocker, Rob Richards, Marcus Boerger
enchant Pierre-Alain Joye, Ilia Alshanetsky
ereg Rasmus Lerdorf, Jim Winstead, Jaakko Hyvätti
EXIF Rasmus Lerdorf, Marcus Boerger
fileinfo Ilia Alshanetsky, Pierre Alain Joye, Scott MacVicar, Derick Rethans
Firebird driver for PDO Ard Biesheuvel
FTP Stefan Esser, Andrew Skalski
GD imaging Rasmus Lerdorf, Stig Bakken, Jim Winstead, Jouni Ahto, Ilia Alshanetsky, Pierre-Alain Joye, Marcus Boerger
GetText Alex Plotnick
GNU GMP support Stanislav Malyshev
Iconv Rui Hirokawa, Stig Bakken, Moriyoshi Koizumi
IMAP Rex Logan, Mark Musone, Brian Wang, Kaj-Michael Lang, Antoni Pamies Olive, Rasmus Lerdorf, Andrew Skalski, Chuck Hagenbuch, Daniel R Kalowsky
Input Filter Rasmus Lerdorf, Derick Rethans, Pierre-Alain Joye, Ilia Alshanetsky
InterBase Jouni Ahto, Andrew Avdeev, Ard Biesheuvel
Internationalization Ed Batutis, Vladimir Iordanov, Dmitry Lakhtyuk, Stanislav Malyshev, Vadim Savchuk, Kirti Velankar
JSON Omar Kilani, Scott MacVicar
LDAP Amitay Isaacs, Eric Warnke, Rasmus Lerdorf, Gerrit Thomson, Stig Venaas
LIBXML Christian Stocker, Rob Richards, Marcus Boerger, Wez Furlong, Shane Caraveo
mcrypt Sascha Schumann, Derick Rethans
MS SQL Frank M. Kromann
Multibyte String Functions Tsukada Takuya, Rui Hirokawa
MySQL driver for PDO George Schlossnagle, Wez Furlong, Ilia Alshanetsky, Johannes Schlueter
MySQL Zeev Suraski, Zak Greant, Georg Richter, Andrey Hristov
MySQLi Zak Greant, Georg Richter, Andrey Hristov, Ulf Wendel
MySQLnd Andrey Hristov, Ulf Wendel, Georg Richter, Johannes Schlüter
OCI8 Stig Bakken, Thies C. Arntzen, Andy Sautins, David Benson, Maxim Maletsky, Harald Radi, Antony Dovgal, Andi Gutmans, Wez Furlong, Christopher Jones, Oracle Corporation
ODBC driver for PDO Wez Furlong
ODBC Stig Bakken, Andreas Karajannis, Frank M. Kromann, Daniel R. Kalowsky
OpenSSL Stig Venaas, Wez Furlong, Sascha Kettler, Scott MacVicar
Oracle (OCI) driver for PDO Wez Furlong
pcntl Jason Greene, Arnaud Le Blanc
Perl Compatible Regexps Andrei Zmievski
PHP Archive Gregory Beaver, Marcus Boerger
PHP Data Objects Wez Furlong, Marcus Boerger, Sterling Hughes, George Schlossnagle, Ilia Alshanetsky
PHP hash Sara Golemon, Rasmus Lerdorf, Stefan Esser, Michael Wallner, Scott MacVicar
Posix Kristian Koehntopp
PostgreSQL driver for PDO Edin Kadribasic, Ilia Alshanetsky
PostgreSQL Jouni Ahto, Zeev Suraski, Yasuo Ohgaki, Chris Kings-Lynne
Pspell Vlad Krupin
Readline Thies C. Arntzen
Recode Kristian Koehntopp
Reflection Marcus Boerger, Timm Friebe, George Schlossnagle, Andrei Zmievski, Johannes Schlueter
Sessions Sascha Schumann, Andrei Zmievski
Shared Memory Operations Slava Poliakov, Ilia Alshanetsky
SimpleXML Sterling Hughes, Marcus Boerger, Rob Richards
SNMP Rasmus Lerdorf, Harrie Hazewinkel, Mike Jackson, Steven Lawrance, Johann Hanne, Boris Lytochkin
SOAP Brad Lafountain, Shane Caraveo, Dmitry Stogov
Sockets Chris Vandomelen, Sterling Hughes, Daniel Beulshausen, Jason Greene
SPL Marcus Boerger, Etienne Kneuss
SQLite 3.x driver for PDO Wez Furlong
SQLite3 Scott MacVicar, Ilia Alshanetsky, Brad Dewar
Sybase-CT Zeev Suraski, Tom May, Timm Friebe
System V Message based IPC Wez Furlong
System V Semaphores Tom May
System V Shared Memory Christian Cartus
tidy John Coggeshall, Ilia Alshanetsky
tokenizer Andrei Zmievski, Johannes Schlueter
WDDX Andrei Zmievski
XML Stig Bakken, Thies C. Arntzen, Sterling Hughes
XMLReader Rob Richards
xmlrpc Dan Libby
XMLWriter Rob Richards, Pierre-Alain Joye
XSL Christian Stocker, Rob Richards
Zip Pierre-Alain Joye, Remi Collet
Zlib Rasmus Lerdorf, Stefan Roehrich, Zeev Suraski, Jade Nicoletti, Michael Wallner
PHP Documentation
Authors Mehdi Achour, Friedhelm Betz, Antony Dovgal, Nuno Lopes, Hannes Magnusson, Georg Richter, Damien Seguy, Jakub Vrana, Adam Harvey, Peter Cowburn
Editor Philip Olson
User Note Maintainers Daniel P. Brown, Thiago Henrique Pojda
Other Contributors Previously active authors, editors and other contributors are listed in the manual.
PHP Quality Assurance Team
Ilia Alshanetsky, Joerg Behrens, Antony Dovgal, Stefan Esser, Moriyoshi Koizumi, Magnus Maatta, Sebastian Nohn, Derick Rethans, Melvyn Sopacua, Jani Taskinen, Pierre-Alain Joye, Dmitry Stogov, Felipe Pena, David Soria Parra, Stanislav Malyshev, Julien Pauli, Stephen Zarkos, Anatol Belski, Remi Collet, Ferenc Kovacs
Websites and Infrastructure team
PHP Websites Team Rasmus Lerdorf, Hannes Magnusson, Philip Olson, Lukas Kahwe Smith, Pierre-Alain Joye, Kalle Sommer Nielsen, Peter Cowburn, Adam Harvey, Ferenc Kovacs, Levi Morrison
Event Maintainers Damien Seguy, Daniel P. Brown
Network Infrastructure Daniel P. Brown
Windows Infrastructure Alex Schoenmaker

PHP License

This program is free software; you can redistribute it and/or modify it under the terms of the PHP License as published by the PHP Group and included in the distribution in the file: LICENSE

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医院经营管理网

行业资讯Industry information

首页>行业资讯>政策解读
CDE再度发文加速临床急需药品上市销售
提交者:九鼎医管 发表时间:2019-11-11 点击次数:3097 来源:新浪医药新闻

医院文化建设


  11月8日,国家药监局药品审评中心发布关于再次公开征求《临床急需药品附条件批准上市技术指导原则》意见的通知,较2017年12月原技术指南,该指导意见稿中明确适用范围为“未在中国境内上市销售,但临床急需的中药、化学药和生物制品。”
  
  该意见稿是根据新版药品管理法、疫苗管理法、药品注册管理办法(征求意见稿),借鉴国际经验,结合我国药品审评工作实践而制定。
  
  临床急需药品附条件批准上市技术指导的出台,将吸引更多创新药优先到中国申请审评和上市,同时也可以激发国内企业以临床需求为驱动,研发出更多的新药。


医院文化建设
  
  该指导意见稿指出,附条件批准上市是指用于治疗严重危及生命且尚无有效治疗手段的疾病以及罕见病的药品、公共卫生方面急需的药品等。此外,还包括未被满足的临床需求如无批准可用的治疗方法、有可用的治疗方法、解决新出现或预期会发生的公共卫生需求。
  
  不久前,国家药监局批准了绿谷制药治疗阿尔茨海默病新药“九期一”(甘露特钠,代号:GV-971)的上市申请。九期一是中国原创、全球首个靶向脑-肠轴的阿尔茨海默病治疗新药,填补了这一领域17年无新药上市的空白。
  
  九期一的出现让中国医药界为之沸腾,而中国的原创新药正在科研努力和政策扶持下进入爆发期。
  
  近日在某会议上,新浪医药从相关人士处知悉,目前国内系统产生创新药的时代未到来,还需要国家监管机构通过智库研究评估药品上市标准体系,平衡好患者可及性和产业健康发展,拿捏好与国家接轨的节奏。
  
  该人士指出,以临床价值为驱动,以患者为核心的创新药研发生态尚未形成,这需要药物创新各相关方共同努力,培育与创新相适应的创新药研发生态。
  
  而类似于临床急需药品附条件批准上市技术指导文件,无疑有助于我国构建全新的创新药研发生态,构建与国际趋同的审评管理体系等。
  
  无独有偶,近日国家发改委发布的区域医疗中心建设试点工作方案也提到鼓励创新药物和技术使用。给予区域医疗中心必要的新技术应用政策,鼓励开展创新药品、医疗器械临床试验,对正在开展临床试验、用于治疗严重危及生命且在我国尚无同品种产品获准注册的医疗器械,逐步在区域医疗中心开展拓展性使用。
  
  鼓励区域医疗中心发挥重点科室优势,对区域内确需使用的、国内尚未注册的少量临床急需药品,依法提出临时进口申请,国家药品监督管理部门加快审批。
  
  在京、沪等地优质医疗资源的输出帮扶下,区域医疗中心有望成为催生创新研发的高地。
  
  另外,值得一提的是,在原技术指南上,该意见稿修订内容包括增加了附条件批准上市药品的药学、药理毒理学要求;附条件批准上市的基本条件增加了疫苗的相关描述;增加了附条件批准上市药品的《药品注册批件》、说明书和标签的描述规定,明确了以补充申请的形式提交附条件批准上市后完成的临床试验以推动药品常规批准上市等。
  
  附临床急需药品附条件批准上市技术指导原则(征求意见稿)
  
  一、前言
  
  为落实《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号),鼓励以临床需求为核心的药物创新,加快具有临床价值的临床急需药品上市,根据《中华人民共和国药品管理法》、《中华人民共和国疫苗管理法》、《药品注册管理办法(征求意见稿)》,借鉴国际经验,结合我国药品审评工作实践,制定本指导原则。
  
  附条件批准上市是指用于治疗严重危及生命且尚无有效治疗手段的疾病以及罕见病的药品、公共卫生方面急需的药品,现有临床研究资料尚未满足常规上市注册的全部要求,但药物临床试验已有数据显示疗效并能预测其临床价值,因临床急需,在规定申请人必须履行特定条件的情况下基于替代终点、中间临床终点或早期临床试验数据而批准上市。其目的是缩短药物临床试验的研发时间,提早应用于无法继续等待的急需病人。附条件批准上市不包括因临床试验设计或执行过程中存在缺陷而不能达到上市许可要求的情况。
  
  通常,附条件批准上市药品的药学、药理毒理学要求与常规批准上市药品相同;对于公共卫生方面急需的药品或应对重大突发公共卫生事件的药品,可根据具体情况,结合药品的获益-风险进行评价。
  
  本指导原则适用于未在中国境内上市销售,但临床急需的中药、化学药和生物制品。
  
  申请人在获得附条件批准上市后,需按照所附的特定条件,开展新的或继续正在进行的临床试验,这些临床试验通常是以确认预期的临床获益为目的的确证性临床试验,为常规上市提供充足证据。
  
  二、附条件批准上市的基本条件
  
  (一)符合以下情形的临床急需药物,可申请附条件批准:
  
  1.目标适应症为严重且危及生命的疾病,其现有治疗手段具有未满足的临床需求,药物临床试验已有数据显示其疗效并能预测其临床获益的;
  
  2.治疗罕见病的临床急需药品,境外已批准上市或境内已有临床数据显示其疗效并能预测其临床获益的;
  
  3.公共卫生方面急需的药品,药物临床试验已有数据显示其疗效并能预测其临床获益的;
  
  4.应对重大突发公共卫生事件急需的疫苗或国家卫生行政部门认定急需并被依法列入特别审批程序的其他疫苗,经评估获益大于风险的。
  
  (二)未被满足的临床需求通常包括以下情况:
  
  1.无批准可用的治疗方法。
  
  2.有可用的治疗方法:当一种疾病存在可用的治疗方法,如果新的治疗药物能满足下述条件之一,通常也被认为可解决未满足的临床需求:
  
  (1)与现有疗法相比,对疾病的预后有明显改善作用;
  
  (2)用于对现有疗法不耐受或无疗效的患者可取得明显疗效;
  
  (3)可以与现有疗法不能联用的其他关键药物或治疗方式有效地联用并取得明显疗效;
  
  (4)疗效与现有疗法相当,但可避免现有疗法的严重毒性,或降低有害的药物相互作用,或显著改善病人的依从性;
  
  3.解决新出现或预期会发生的公共卫生需求。
  
  三、附条件批准药物的疗效评价
  
  对于临床急需药物,可基于替代终点、中间临床终点或早期临床试验数据而附条件批准上市。申请人应说明所选择的替代终点、中间临床终点或选择早期临床试验数据与预期的临床获益之间的相关性、合理性,并提供相应的证据。
  
  1.有效性评价终点指标
  
  通常用于药物有效性评价的指标应为临床终点。临床终点是指可以直接测量药物疗效的特征或变量,即药物对患者感觉(例如症状缓解)、功能(例如运动性改善、延缓或阻止功能衰退等)或生存影响的直接评价。
  
  用于附条件批准临床急需药品上市的有效性评价终点通常有两类:
  
  (1)很可能预测临床获益的替代终点。替代终点一般是一个生物标志物,可以是实验室检查项目、放射影像学、体征或其他指标,其本身并不衡量临床获益,但可以预测临床获益。依据其对临床获益的预测能力,替代终点可以是已知可以合理预测临床获益的指标,或者是很可能预测临床获益的指标。
  
  (2)可以早期评估临床获益的中间临床终点。中间临床终点一般是指在治疗慢性疾病的临床获益评价中,通常认为短期临床获益很可能预测长期临床获益。例如,治疗多发性硬化病的药物在获得常规批准时需要提供2年的用药临床疗效评价,而在附条件批准时,中间临床终点指标则是1年的用药疗效评价。
  
  在确证性临床试验中,应用替代终点指标或中间临床终点指标的研究结果可以合理预测该产品很可能具有疗效和临床获益的,可给予附条件批准上市。
  
  2.早期临床试验数据
  
  早期临床试验数据通常是指在开展确证性临床试验前所获得的临床数据。根据早期临床试验数据,可合理预测或判断其临床获益的,可以在完成确证性临床试验前给予附条件批准上市。
  
  3.境外临床试验数据
  
  境外已批准上市的治疗罕见病的临床急需药品,基于境外临床试验数据,可以在完成种族敏感性试验前给予附条件批准上市。
  
  四、附条件批准上市的申请
  
  (一)沟通交流
  
  1.临床试验开展前
  
  申请人在附条件批准上市的临床试验开展前,应与国家药品监督管理局药品审评中心(以下简称药审中心)进行沟通交流,以明确下列问题:
  
  (1)临床试验中所选择的替代终点指标的合理性及其可合理预测临床获益的标准或
  
  (2)临床试验中中间临床终点指标的选择及其可合理预测临床获益的标准或
  
  (3)对早期临床试验数据的要求,包括疗效评价的指标和标准,可合理预测临床获益的依据。
  
  (4)上市后临床试验的设计和实施计划。
  
  (5)其他附条件批准的前提条件,包括药学、药理毒理学研究等。
  
  沟通会议纪要将作为附条件批准上市申请的受理、立卷审查和审评审批的重要依据。
  
  2.提交上市申请前
  
  申请附条件批准上市前,申请人应当就已有临床试验数据、药学和药理毒理学数据、申请附条件批准上市的意向以及上市后继续完成的研究工作、上市后风险控制计划等与药审中心进行沟通交流。经沟通交流确认后,可提出药品上市注册申请。
  
  (二)提交上市申请的要求
  
  根据替代终点指标而附条件批准上市的,申请人应在申请上市许可时提交承诺的上市后确证性临床研究计划和方案以及完成期限、上市后风险控制计划等。
  
  根据中间临床终点而附条件批准上市的,申请人需承诺按已确定的临床试验方案完成临床试验并提交上市后风险控制计划。
  
  根据早期临床试验数据附条件批准上市的,申请人应在申请上市许可时提交后续临床研究计划和方案以及完成期限、上市后风险控制计划等。
  
  已在境外批准上市的治疗罕见病的药品,申请人需按照我国相关要求提交支持其境外批准上市的临床试验数据以及种族敏感性研究的计划和方案、风险控制计划。
  
  在上市申请审评期间,申请人与药审中心可进一步就上述内容讨论确定并达成一致意见,申请人应按时完成所有承诺的临床试验。
  
  五、附条件批准上市的上市后要求
  
  对附条件批准的药品,国家药监局将以《药品注册批件》附件的形式将药品上市所附条件以及申请人承诺的研究和完成期限通知药品上市许可持有人。
  
  在药品说明书【适应症】和【临床试验】项下,应注明本品为基于替代终点(或中间临床终点或早期临床试验数据)获得附条件批准上市,尚未获得临床终点数据,有效性和安全性有待上市后进一步确证;【批准文号】项下应注明“附条件批准上市”字样。药品标签中相关内容应与说明书保持一致。
  
  药品上市许可持有人应当在药品上市后采取相应的风险管理措施,保证患者用药安全。并在规定期限内按要求完成承诺的药物临床试验等相关研究,以补充申请方式报药审中心申请常规批准上市。
  
  附条件批准上市后开展新的或继续进行的临床试验,仍需符合《药物临床试验质量管理规范》的相关要求。
  
  六、附条件批准上市的撤销
  
  有以下情形之一的,国家药品监督管理局依法处理,直至注销附条件批准药品的药品注册证书:
  
  (一)逾期未按要求完成后续相关研究且无合理理由的;
  
  (二)要求证实药品预测临床获益的试验未能证实该获益的;
  
  (三)上市后临床研究结果经审评不能证明获益大于风险的;
  
  (四)其他不符合继续上市条件的情形。
  
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