| 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.
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