【完美总结】2015年全年新政策+英文版全年汇总.PDF - 药群论坛

The following pharmaceutical-related policies, regulations and laws are proposed and under drafting process by early 2016.

Amendment  of the Drug Administration Law of PRC - CFDA initiated the amendment  process of the Drug Administration Law of PRC before the end of 2013. It also  sought public comments over the amendment on January 7, 2014. The existing  Drug Administration Law was promulgated in 1985. The Law was amended previously  seven times and last one was made on April 24, 2015.  Thereafter, CFDA  has continued its process to revise the Drug Administration Lawof PRC comprehensively.

  On the other hand, CFDA continues its process to revise the Drug  Administration Lawof PRC comprehensively. CFDA Vice Minister JIAO Hong  reported on the latest developments in the amendment of the of Drug  Administration Law PRC at a pharma policy conference in late 2015. Jiao  stated that the final draft of the amendment is scheduled by the CFDA for  submission to the Legislation Office of the State Council at the end of 2016.  She outlined the following aspects which will be reflected in the amendment:

  · Transforming the core spirit of Chinese drug regulation from  "drug administration" to "drug control". Future drug  regulation, she said, will be carried out surrounding risks to ensure full  process and classified control. Pharmaceutical manufacturers should be the  first liability holder of drug safety, while the government has regulatory responsibilities.  The responsibilities of the two must be clarified.

  · Further improvement of the Chinese drug regulatory system. The  requirements of the State Council for decentralization will be facilitated  and they include: combination of drug manufacture license and GMP  certification, combination of drug distribution license and GSP  certification, as well as decentralization of GMP certification, drug  registration renewal, supplemental drug registration not related to internal  quality of drugs and drug contract manufacture. Jiao said the CFDA is  researching on how these reforms can be executed and managed. Other aspects  to be covered by the amendment include the marketing authorization holders  system, quality authorized person system, drug alert system, deficiency  product recall system, compensation system for drug damages, manufacturer  self-inspection system, arranged responsibility inspection system,  unannounced inspection system, emergency reserve management system.

  · The "four most" spirit of the State Council for drug  regulation will be reflected in the amendment (namely "the most  stringent standards, the most strict supervision, the most severe punishment  and the most serious accountability"). Future drug regulation will  not only focus on meeting quality standard endpoints, but also on the entire  process of fulfilling quality standards. GXP compliance will be provided in  the amendment with supplier audit strengthened and GMP extended to cover  excipients, APIs and packaging materials. Requirements for logistics and  distribution companies over the distribution process, warehousing and  transportation will be stipulated in the amendment. In addition, relevant  facilities involved with drug usage will be included in drug regulation, and  clinical appraisal, surveillance and early warning alert of drug consumption  will be covered. Drug regulatory agencies will be given authority to conduct  extended inspection with more severe punishment for violations.

  · Innovating drug regulatory regime to improve efficiency. On the basis  of understanding the interest of all stakeholders, mechanisms of motivation,  discipline, reward and punishment will be established to combine external  discipline, motivation and pressure and to involve stakeholders in the drug  quality process. Dynamic and unannounced inspections will be combined to  identify problems timely, big data will be used to establish the intelligent  drug regulatory system, and (pharma industry) credit rating system will be  built.

  The Marketing Authorization Holder (MAH) model for drug approval - The  current Chinese approach to drug approval is to bundle marketing and  production authorizations together, compared with separated marketing and  production authorizations in Western developed nations. The existing Chinese  approach may create many legal ambiguities and vacuums for liabilities in  today's pharmaceutical sector where licensing, technology transfer and  contract manufacturing are common place. Proposal for authorizing the State  Council to conduct experiments of the Drug Marketing Authorized Holder System  has been reviewed and approved in November 2015 by the Executive Committee of  the National People's Congress (NPC). The term of the experiment is going to  be two years. Following completion of them, proposals for relevant amendment  of the Drug Administration Law of PRC, which are developed on the  basis of successful experiences, should be submitted for review by the  Executive Committee of the People’s Congress;

  Amendment of the  Provisions for Drug Registration - CFDA issued drafts of this  regulation in November 2013 and February 2014 respectively to solicit public  comments on its proposed amendments to the Provisions for Drug  Registration. The amendment aims to update the regulation, which was  issued in 2007, in areas including dosage form changes, new drug application,  linkage with latest patent law amendments, new drug surveillance period, and  onsite inspection of generic drug applications;

  Testing Guidelines  for Imported Drug Registration - The Drug and Cosmetic Registration  Department of CFDA issued the draft document in July 2015 to the provincial  level food and drug administration for comments from relevant entities in  their respective territories.

  Rules for Reconsideration of Drug Registration Technical Evaluation  (Interim) – CDE issued a notice on December 25, 2015 to solicit  public comments on its draft. According to the draft document, the regulation  is applicable to those drug applications rejected by the CDE. Reconsideration  in the context of this regulation refers to the process whereby the  reconsideration expert committee, made up by third party experts, openly  hears comments from both CDE reviewers and drug applicants over disputed  technical issues of drug evaluation in the form of meetings, and makes final decisions  in the principle of majority votes.

  General Considerations for Drug Clinical Trials - CDE issued  the draft document on December 21, 2015 for public comments. The purpose of  the document is "to provide technical guidance to drug applicants and researchers  for the development of drug R&D strategy and for specific clinical  trials, as well as setting references for drug technical evaluation".  The document can also be referenced for clinical trials of marketed drugs for  the purpose of establishing new indications. The document is primarily  applicable to chemical drugs and therapeutic biologics.

  Technical Guidelines for Clinical Trials of Pediatric Drugs  - CDE issued the draft document in August 2015 for public comments. The  proposed document provides key requirements for clinical trials of pediatric  drugs and seeks to streamline protocol design and improve quality of such  trials.

  Rules for Filing of Bioequivalence Studies of Chemical Generic Drugs-  The CFDA issued in November 2015 the draft regulation, which covers filing  and relevant regulation of bioequivalence (BE) studies of chemical generic  drugs for the purpose of drug registration and evaluation of quality and  therapeutic efficacy equivalence, as well as a separate official notice to  seek public comments on four related draft technical guidelines: 1) Guidelines  for Selection and Ascertainment of Reference Formulations for Regular Oral  Solid Dosage Form Drug Preparations; 2) Guidelines for Dissolution  Curve Measurement and Comparison of Regular Oral Solid Dosage Form Drug  Preparations; 3) Technical Guidelines for Human Bioequivalence Study  of Generic Drug Quality; and 4) Opinions for Conducting Quality and  Efficacy Equivalence Study of Generic Drugs.

  Technical Guideline for Bioequivalence Studies of Chemical Drugs with  Pharmacokinetic Parameters as End Points Rules for Drug Technical Evaluation  Communications - CDE released the draft document in late 2015 for  public comments.

  Technical Guideline for Clinical Similarity Research of Vaccines  – CDE drafted in October 2015 the document in an effort to streamline  clinical research of vaccines, ensure homogenicity of approved vaccines in  terms of safety and efficacy, as well as guide and regulate clinical  similarity research for registration of vaccines. The guideline will be  applicable to experimental vaccines (with existing national standards or  approved similar vaccines) which propose to carry out clinical similarity  research against marketed similar vaccines. CDE said the document can also be  referenced for vaccine clinical research involving changes relating to  formulas, origins, production processes, etc.

  Rules for Batch Release of Biological Products – CFDA issued  the draft of this document in late 2015 in an effort to safeguard quality of  biological products.

Rules  for Drug Technical Evaluation Communications- CDE issued the draft document in  late 2015 for public comments.

  Provisions for Registration of Medical Institution Formulations–  CFDA issued in January 2015 the draft of this regulation for public  feedbacks. According to the proposed regulation, drug formulations made by  medical institutions are banned from being sold or sold in kind on the market  and their advertisements are also forbidden. Such formulations can only be  used in the formulating medical institutions with prescriptions of licensed  physicians or assistant physicians. Indications of such formulations must be  in line with approved therapeutic scopes of the formulating medical  institutions. Relevant preclinical studies must be carried out before  applications for clinical research. All active pharmaceutical ingredients  used in hospital formulations must have drug approvals and meet relevant drug  standards.

  Provisions for Food and Drug Complaints and Reports – With its  draft released in December 2014, the proposed regulation has a total of five  chapters and 42 articles covering general principles, acceptance (of  complaints and reports, operating procedures), information management and  supervision & accountability.

  The Provisions for Drug Prices – Originally scheduled for  release in late 2009, the launch of this regulation has been delayed  repeatedly due to intensive debates. But the NDRC managed to complete its  second draft of the regulation before the end of 2010. In May 2015, the NDRC,  in association with the NHFPC and the MOHRSS, issued a drug price reform  policy, Opinions for Advancing Drug Price Reform, which officially  withdraws government price setting of all drug products except narcotics and  class 1 psychoactives. The regulation is likely to be revised again at a  later stage when the new policy regime fall into places.

  Provisions for Internet Sales of Food and Drugs - CFDA released  in May 2014 its draft for public comments. However, the CFDA has put the  proposed regulation on hold indefinitely, following arrival of the new CFDA  leadership in early 2015, due to challenges of regulating online prescription  drug sales.

  Fourth Amendment to the Chinese Patent Law – Issued in  September 2013 for public comments. The two key components of the  proposed amendment include: 1) giving SIPO more power to administratively  enforce the patent laws; and 2) increasing the amount of damages available in  patent infringement cases. On December 2, 2015, the Legal Affairs Office of  the State Council published a new draft of the fourth amendment to solicit  public comments before January 1, 2016. Compared with the last draft which  was published on April 1, 2015, this version includes some additional  contents.

  Traditional Chinese Medicine Law of PRC – The National  People's Congress began to read the Law in December 2015, which calls for a  strengthened role of TCM in China's health care system. The draft law was  passed earlier this month by the State Council. The draft law also vows to  expand TCM's role in dealing with emergency public health incidents and  diseases prevention and controls, strengthening policy support for TCM,  making policies to allow TCM medical fees to be covered by basic medical  insurance schemes. It calls for maintaining the characteristics of TCM, using  TCM methodologies to provide health services, improving the quality of TCM  materials and encouraging medical institutions to use TCM preparations.

  Basic Medical and Healthcare Law of PRC – It was researched and  drafted by relevant departments of the State Council in early 2013. The NHFPC  made progress on this front in 2014 and managed to put the law on the  five-year legislation plan of the National People's Congress.

  The following proposed regulations were drafted years ago but there have been  no reported progress in recent years.

  Provisions for Drug Standards – This proposed new regulation, which  provides rules and procedures for development, revision, introduction and  implementation of drug standards, was proposed by the SFDA in 2011. No  progress had been reported by early 2016;

  Administrative Measures for the Inspection of Overseas Drug Manufacturers  and the Notice on Issues Related to Electronic Regulation of Imported  Drugs – They were issued in September 2012 for comments and aim to  strengthen regulation and streamline manufacturing of imported drugs in order  to secure their quality and safety. No progress was reported by early 2016;

  Rules for Food and Drug Safety Interviews - The SFDA released a draft  for public comments on September 26, 2011. According to the draft, food and  drug safety interview refers to a meeting set up by the food and drug  authorities with responsible persons in manufacturing, distribution and  R&D companies of drugs, medical devices, health foods and cosmetics as  well as medical institutions and food service providers over potential food  and drug quality and safety risks;

  Rules for Food and Drug Safety Blacklist - CFDA released this draft  regulation for public comments in December 2013. Information on producers  which "have seriously violated laws and regulations concerning food,  drugs, medical appliances and cosmetics; management and received  administrative penalties" will be made public through government  websites, says the draft regulation. no progress had been reported by early  2016;

  Provisions for Drug Distribution Licenses – Revision of this  regulation is still not completed despite release of the 2013 GSP. A draft  was released for public comments in October 2011. The subject area of  pharmaceutical manufacturer and distributor licensing is likely to be  addressed as a part of the proposed amendment to the Drug Administration  Law of PRC; and

The Provisions for Evaluation of Drug Advertisements – Revision of this regulation was proposed by the SFDA in October 2012 to ban advertising of OTC drugs on mass media. The agency hesitated in the face of strong industry opposition and no progress had been reported by early 2016.

2015年1-11月新政收集
序号	名称
1	20150130国家食品药品监督管理总局关于发布国际多中心药物临床试验指南（试行）的通告（2015年第2号）.pdf
2	20150424中华人民共和国药品管理法及对比.pdf
3	20150527国家食品药品监督管理总局关于发布药品、医疗器械产品注册收费标准的公告（2015年第53号）.pdf
4	20150608关于开展临床试验药物生产质量管理情况调研的通知.pdf
5	20150715国家食品药品监督管理总局关于实施《中华人民共和国药典》2015年版有关事宜的公告（2015年第105号）.pdf
6	20150722国家食品药品监督管理总局关于开展药物临床试验数据自查核查工作的公告（2015年第117号）.pdf
7	20150730食品药品监管总局关于进一步规范药品注册受理工作的通知2015（122号文）.pdf
8	20150731国家食品药品监督管理总局关于征求加快解决药品注册申请积压问题的若干政策意见的公告（2015年第140号）.pdf
9	20150731食品药品监管总局召开药物临床试验数据自查核查工作电视电话会议.pdf
10	20150803关于公布化药新药生产工艺信息表相关事宜的通知.pdf
11	20150807关于召开药物临床试验数据自查核查工作会议的通知.pdf
12	20150818国务院关于改革药品医疗器械审评审批制度的意见国发〔2015〕44号pdf.pdf
13	20150818国新办就药品医疗器械审评审批制度改革情况举行新闻发布会.pdf
14	20150818食品药品监管总局召开药物临床试验数据自查核查工作第二次电视电话会议.pdf
15	20150819国家食品药品监督管理总局关于进一步做好药物临床试验数据自查核查工作有关事宜的公告（2015年第166号） .pdf
16	20150825全国药品审评审批制度改革工作会议在上海召开.pdf
17	20150828国家食品药品监督管理总局关于药物临床试验数据自查情况的公告（2015年第169号）.pdf
18	20150909国家食品药品监督管理总局关于药物临床试验机构和合同研究组织开展临床试验情况的公告(2015年第172号).pdf
19	20150924国家食品药品监督管理总局国家卫生和计划生育委员会中国人民解放军总后勤部卫生部关于开展药物临床试验机构自查的公告（2015年第197号） .pdf
20	20151014化学药品注册分类改革（讨论稿）.pdf
21	20151015国家食品药品监督管理总局关于药物临床试验数据自查核查撤回注册申请情况的公告（2015年第201号） .pdf
22	20151016食药监第229号药品审评审批制市改革分工.pdf
23	20151030食品药品监管总局办公厅关于征求普通口服固体制剂参比制剂选择和确定指导原则等意见的通知.pdf
24	20151106关于征求药品上市许可持有人制度试点方案和化学药品注册分类改革工作方案两个征求意见稿意见的公告.pdf
25	20151106国家食品药品监督管理总局关于广东百科制药有限公司等八个企业撤回注册申请的公告（2015年第222号）.pdf
26	20151106国家食品药品监督管理总局关于征求化学仿制药生物等效性试验备案管理规定（征求意见稿）意见的公告（2015年第221号）.pdf
27	20151110国家食品药品监督管理总局关于发布药物临床试验数据现场核查要点的公告（2015年第228号）.pdf
28	20151111国家食品药品监督管理总局关于8家企业11个药品注册申请不予批准的公告（2015年第229号）.pdf
29	20151111国家食品药品监督管理总局关于药品注册审评审批若干政策的公告(2015年第230号).pdf
30	20151113国家食品药品监督管理总局关于征求《关于解决药品注册申请积压实行优先审评审批的意见（征求意见稿）》意见的公告（2015年第227号） .pdf