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12-17

Notice Regarding Matters Concerning the Certificate of Pharmaceutical Product Approval (CPP) for Marketing Authorization

Given the FDA’s adjustment to its policy on CPP documents, it is agreed that for FDA-approved drugs exported from countries other than the United States, the CPP document will no longer be required when filing a registration application in China. Instead, applicants may submit a screenshot of the FDA website or other supporting documentation to substantiate the information provided in the registration application.

12-17

The National Medical Products Administration’s Notice on Implementing the 2020 Edition of the Pharmacopoeia of the People’s Republic of China

The 2020 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) has been published by the National Medical Products Administration and the National Health Commission in Announcement No. 78 of 2020 and shall come into effect as of December 30, 2020. The following announcement is hereby made regarding matters related to the implementation of this edition of the Chinese Pharmacopoeia:

12-17

Announcement by the National Medical Products Administration on the Reissuance of Drug Registration Fee Standards

In accordance with the “Measures for the Administration of Drug Registration” (Order No. 27 of the State Administration for Market Regulation), the “Notice on Reissuing the List of Administrative and Public Service Charges Managed by Central Authorities in the Food and Drug Administration” (Cai Shui [2015] No. 2), and the “Notice on Issuing the ‘Administrative Measures for Fee Standards for Drug and Medical Device Product Registration’” (Fa Gai Jia Ge [2015] No. 1006), the National Medical Products Administration has formulated the “Fee Standards for Drug Registration” and the “Detailed Implementation Rules for Drug Registration Fees.” These are hereby promulgated and shall take effect as of July 1, 2020.

12-17

The Center for Drug Evaluation of the National Medical Products Administration Releases the “Technical Guidance Principles for the Design and Research of Functional Score Lines on Oral Tablets of Generic Chemical Drugs”

To promote the research and development of chemically generic oral solid dosage forms, under the guidance of the National Medical Products Administration, the Center for Drug Evaluation has organized the formulation of the “Technical Guidance Principles for the Design and Research of Functional Score Lines in Chemically Generic Oral Tablets (Trial)” (see attachment). In accordance with the requirements of the “Notice from the Comprehensive Department of the National Medical Products Administration on Issuing the Procedures for Publishing Pharmaceutical Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), and after review and approval by the National Medical Products Administration, these principles are hereby released and shall take effect as of the date of their publication.

12-17

The National Medical Products Administration’s Announcement on the Release of Classification of Chemical Drug Registration and Requirements for Submission of Application Materials

To align with the implementation of the “Measures for the Administration of Drug Registration,” the National Medical Products Administration has organized the development of the “Classification of Chemical Drug Registration and Requirements for Submission of Regulatory Documents.” This document is hereby released, with the following clarifications:

12-17

Drugs already marketed overseas but not yet marketed domestically

The approval and launch of drugs already marketed overseas in China, or their generic versions, represents an important approach to addressing the accessibility and availability of medicines that urgently meet clinical needs among Chinese patients. To accelerate the development and approval process for such drugs and strengthen scientific regulation, the Center for Drug Evaluation has, in accordance with the "Measures for Drug Registration Administration" (General Administration Order No. 27) and its supporting documents, formulated the "Clinical Technical Requirements for Drugs Already Marketed Overseas but Not Yet Marketed in China" (see attachment). In compliance with the requirements of the "Notice from the Comprehensive Division of the National Medical Products Administration on Issuing Procedures for the Publication of Pharmaceutical Technical Guidelines" (NMPA Comprehensive Drug Administration [2020] No. 9), and following review and approval by the National Medical Products Administration, these requirements are hereby released.

12-17

The National Medical Products Administration’s Announcement on the Release of Registration Categories and Data Requirements for Biological Products

To align with the implementation of the “Measures for the Administration of Drug Registration,” the National Medical Products Administration has organized the development of the “Classification of Biological Product Registration and Requirements for Submission of Application Materials.” This document is hereby released, and the following clarifications are provided:

12-17

The Center for Drug Evaluation of the National Medical Products Administration’s Drug Review Center has released the “Technical Guidance Principles for Conditional Approval of Drugs for Market Launch.”

　　According to the “Announcement of the National Medical Products Administration on Matters Relating to the Implementation of the ‘Measures for the Administration of Drug Registration’” (No. 46 of 2020), in order to advance the drafting and formulation of relevant supporting normative documents and technical guidance principles, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation has developed the “Technical Guidance Principles for Conditional Approval of Drug Marketing (Trial)” (see attachment). In accordance with the requirements of the “Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedures for the Publication of Drug Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), after review and approval by the National Medical Products Administration, this document is hereby released and shall take effect from the date of its publication.

12-17

Drug Administration Law of the People's Republic of China

(Adopted at the 7th Session of the Standing Committee of the Sixth National People's Congress on September 20, 1984; first revised at the 20th Session of the Standing Committee of the Ninth National People's Congress on February 28, 2001) First amended pursuant to the Decision on Amending Seven Laws, including the Law of the People's Republic of China on Marine Environmental Protection, adopted at the 6th Session of the Standing Committee of the 12th National People's Congress on December 28, 2013 First amended pursuant to the Decision on Amending the Law of the People's Republic of China, adopted at the 14th Session of the Standing Committee of the 12th National People's Congress on April 24, 2015

12-17

The National Medical Products Administration’s Announcement on the Release of Requirements for Management of Pharmaceutical Records and Data

To implement the relevant provisions of the Drug Administration Law and the Vaccine Administration Law, strengthen the recording and data management of drug research and development, production, distribution, and use activities, and ensure that the relevant information is authentic, accurate, complete, and traceable, the National Medical Products Administration has organized the formulation of the “Requirements for Drug Records and Data Management (Trial Implementation).” These requirements are hereby promulgated and shall take effect as of December 1, 2020.

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