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监管机构资讯

2020
Q4 Regulatory Newsletter
Feb. 26, 2021
Q4 Regulatory Newsletter
WuXi Biologics Regulatory Updates
Quarter 4 – 2020

WuXi Biologics’ Regulatory Affairs team is honored to provide you with a summary of what we deem as the relevant (i.e., product development and CMC-related) regulatory updates organized by agency and by topic. We have compiled these updates to support your efforts to stay current in the ever-changing regulatory environment for biological therapeutics and vaccines.

 

Purpose & Disclaimer: The intent of this update is to provide the global regulatory agencies’ updates and new or revised documents during the period stated here. The items listed should neither be considered comprehensive nor exhaustive of all updates from the regulatory agencies but as such, the list contains items that the WuXi Biologics’ Regulatory Affairs team deems relevant to our potential or existing clients and partners developing biological therapeutics and vaccines. Therefore, this update is for information purposes only and is provided “as is” without any warranty, expressed or implied, as to the completeness or accuracy of the contents or its use or fitness for a particular purpose. Without limiting the generality of the foregoing, the document and information contained therein should not be construed as regulatory advice or representing, speaking or acting for any regulatory agency. The information is provided to support your efforts to remain informed and should not be used as a substitute for your own regulatory due diligence or actions

 

Quick Links to Agency Sections: U.S. Food & Drug Administration (FDA) | European Medicines Agency (EMA) | Health Canada | World Health Organization (WHO) | U.S.Pharmacopoeia | Pharmaceuticals and Medical Devices Agency (PMDA) | Australian Department of Health Therapeutic Goods Administration (TGA) | MHRA – Medicines and Healthcare Products Regulatory Agency | International Council for Harmonisation (ICH) | National Medical Products Administration (NMPA)

 

Other updates:

 

 

 U.S.FDA

Regulatory Submission and Procedure Updates

 

 

Vaccines, Gene Therapy, and Advanced Therapy Medicinal Products Updates

 

 EU/EMA

 

Regulatory Submission and Procedure Updates

 

 
This guidance (revision 10) provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to applicants in preparing their request. It also explains the scope and nature of scientific advice and protocol assistance. It is updated regularly to reflect new developments and include accumulated experience. In particular, this version was amended to modify the submission process.

 

 

Drug Development and Quality Guideline Updates

 

 

Vaccines, Gene Therapy, and Advanced Therapy Medicinal Products Updates

 

Health Canada

 

Drug Development and Quality Guideline Updates

 

 

Regulatory Submission and Procedure Updates

 

 

WHO

 

Drug Development and Quality Guideline Updates

 

U.S.Pharmacopoeia

 

 

United States Pharmacopeia – National Formulary (USP-NF)


 In response to the COVID-19 pandemic, the USP Council of Experts voted in late March to extend the implementation dates for USP-NF in efforts to provide stakeholders flexibility to be in compliance with upcoming revisions. As a result, both USP 43-NF 38 and USP 43-NF 38, First Supplement became official at the same time, on November 1st, 2020. USP 43-NF 38, Second Supplement became official one month later, on December 1st, 2020.

 

PMDA

 

Drug Development and Quality Guideline Updates

 

TGA

 

Regulatory Submission and Procedure Updates

 

MHRA

 

Drug Development and Quality Guideline Updates

 

 

Regulatory Submission and Procedure Updates

 

ICH



Regulatory Submission and Procedure Updates

 

 

NMPA

 

China reviews and amends the Patent Law (November 2020)

China’s Patent Law (“CPL”) was reviewed in October 2020 to amend the law and will take effect on June 1, 2021. The new CPL reveals China’s efforts to create a legal system better able to protect patentee rights and to attract new patent filings. The law pursues these goals by increasing infringement penalties, thus strengthening their deterrent effect, further regulating the burden of proof, improving the administrative law enforcement, and enhancing the effectiveness and efficiency of the patent protection regime.
Even though the CPL sets good premises, it outlines principles that cannot always be directly applied without additional regulations aimed at establishing more detailed rules that will enable the consistent implementation of the new CPL. Hence, the impact of the new Chinese Patent Law will have to be evaluated based on the implementing regulations and practical application of the law. Particular attention must also be paid to the court decisions on patent infringement cases.

China NMPA released Technical Guidelines for Conditional Approvals of Drug (November 2020)
On November 8, 2020, the NMPA issued the technical guidelines for conditional approvals of drugs in urgent clinical needs (Interim). The document took effect immediately on the date of release.

China NMPA Solicits Public Comments on the Requirements of the Annual Drug Report Management and the Draft Request for Comments of the Annual Drug Report Template (December 2020)
On December 12, 2020, the NMPA Center for Drug Evaluation (CDE) issued administrative rules titled “Management Guidance/Standard for Periodic Safety Update Report”. Marketing Authorization Holders (MAHs) shall establish and implement the Periodic Safety Update Report (PSUR) and submit it to the regulatory agency as required. Where MAH is an overseas enterprise, the corporate legal person designated by it within the territory of China shall submit an annual report according to law.

China NMPA Issues New Guidance Quality Agreement on Contract Manufacturing Arrangements for Drugs (September 2020)
On September 27, 2020, following the amended Drug Administration Law effective on December 1, 2019, China National Medical Products Administration (NMPA) published the new Guidance on Quality Agreements for Contract Manufacturing Arrangements of Drugs in China (the Guidance). The Guidance includes a template quality agreement and sets forth the regulatory aspects of contract drug manufacturing that the NMPA will focus on its audits and inspections. The sample quality agreement provided by the NMPA only aims to cover each party’s fundamental and basic responsibilities. It is highly recommended that the MAH, who is legally required to take primary responsibility, negotiates in detail and conducts a thorough review of the quality agreement with the potential manufacturer before entering into the contract manufacturing arrangement. It is also important for the parties to establish an effective means of communication and specify in the quality agreement the main contact and person in charge of technical and quality matters in case any issue arises in the performance of the quality agreement. The communication results and agreed solutions should be recorded in writing and properly signed by the authorized representatives of each party (who are usually the parties’ legal representatives or the duly authorized individuals in charge of quality control).

China NMPA Rolls out Drug Information Traceability System for Key Drug Products (October 2020)
On October 10, 2020, the NMPA made an announcement in relation to Drug Information Traceability System for key drug products (Circular No. 2020/111)
Marketing authorization holders (MAHs) take the main responsibility for establishing the system and collecting drug traceability information over the whole lifecycle to be able to ensure that national centralized procurement winning bids, narcotic drugs, psychotropic drugs, and blood products are traceable before December 31, 2020. MAHs and drug distributors shall establish and implement drug traceability systems in accordance with the “Guidelines for the Construction of Drug Information Traceability” and other standards and regulations, provide traceability information, and ensure that drugs are traceable. MAH shall bear the main responsibility for the construction of the traceability system. MAH can build the traceability system on their own or entrust the construction to a third-party technical organization in accordance with the unified drug traceability coding requirements in which each level of packaging units is assigned a unique traceability identification code. The traceability code for the same drug can only be traced in the same traceability system. If the company wants to change the traceability code or the traceability system, it can make changes on the collaborative platform as required. When storing products after manufacturing, the information should be stored in the traceability system. During the sale of the drugs, the traceability system should be used to provide relevant traceability information to downstream enterprises or medical institutions so that downstream enterprises or medical institutions can verify. MAH ensures timely and accurate information on the entire lifecycle of the drug can be obtained.

CDE Issues the Guidelines for Management of Supplemental Information. 2020-11-25
The NMPA Center for Drug Evaluation (CDE) issued the CDE Guidelines for Management of Supplemental Information (Interim) on November 25, 2020. The document went into effect on December 1, 2020.

China NMPA Issues Regulation on the Consultation for Drug R&D Activities and Technical Review (December 2020)
The NMPA Center for Drug Evaluation (CDE) issued the Regulation on the Consultation for Drug R&D Activities and Technical Review on December 10, 2020. The document categorizes the types of suitable meetings as well as the preparation procedures and timeline before, during and after the meeting. The document went into effect on the same day of issuance.

China NMPA Issues Measures on Disclosure of Information on Drug Reviews and Approvals (December 2020)
On December 31, 2020, the NMPA Center for Drug Evaluation (CDE) issued Measures on the Publication of Information on Drug Review and Approval, which will be in effect on June 1, 2021.

 

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