On July 2, 2020, the National Medical Products Administration (NMPA) and the National Health Commission of the People’s Republic of China (NHC) announced the Chinese Pharmacopoeia 2020 Edition.

• Read NMPA announces the implementation of the Chinese Pharmacopoeia 2020 edition

This is the 11th edition of Chinese Pharmacopoeia and will be officially implemented from December 30, 2020.

The Chinese Pharmacopoeia is published in 4 volumes:

Volume I:

Traditional Chinese medicines including medicinal materials, cut crude drugs, vegetable oils and extracts, formulation preparation and single flavour preparation;

Volume II:

Chemical drugs, antibiotics, biochemical drugs and radioactive drugs;

Volume III:

Biologics;

Volume IV:

General chapters for finished dosage forms, test methods, guidelines, reference substances, regents, test solutions, and pharmaceutical excipients.

1. Basic Information of Chinese Pharmacopoeia 2020 Edition

The Chinese Pharmacopoeia 2020 edition was compiled under a fixed framework. All goals under the framework have been achieved.

Achievement 1

An appropriate amount of finished pharmaceutical products have been newly listed in the 2020 edition.

This gives a total of 5,911 finished pharmaceutical products listed in the Chinese Pharmacopoeia.

Achievement 2

The 2020 edition deleted several standards of China finished pharmaceutical products to meet the new requirements.

Achievement 3

The 2020 edition comprehensively optimizes the standards of finished pharmaceutical products.

Technical requirements of quality control have been improved for:

• Traditional Chinese medicines,
• Chemical drugs,
• Biological products,
• APIs,
• Pharmaceutical excipients,
• Packaging materials,
• Reference substances.

General notices, general chapters of finished dosage forms, test methods and guidelines have been revised.

Achievement 4

The Chinese Pharmacopoeia 2020 edition has established and optimized the general naming conventions for standard drugs, pharmaceutical excipients and packaging materials.

Achievement 5

The Chinese Pharmacopoeia 2020 edition has improved common technical requirements for finished pharmaceutical products.

For example, the standards of traditional Chinese medicines are maintained at international standards, whereas the standards of chemical drugs and pharmaceutical excipients have nearly approached the international level.

Meanwhile, the standards of biological products have reached the international level and are closely related to novel scientific development.

Achievement 6

The international communication and cooperation between pharmacopoeia authorities has been further strengthened.

A variety of national pharmacopoeias have been further harmonized with each other and the international impact of Chinese Pharmacopoeia has been amplified.

2. Chinese Pharmacopoeia 2015 Edition VS 2020 Edition

You can find the differences between the number of products listed in the 2015 edition and 2020 edition of Chinese Pharmacopoeia below (Table 1).

]]> https://www.accestra.com/china-drug-administration-law-draft-key-amendments-round-2/ Fri, 26 Apr 2019 09:17:27 +0000 http://www.accestra.com/?p=2282 On 20^th of April 2019, the 10^th Standing Committee meeting of the Thirteenth National People’s Congress in China (“NPC“) was held in Beijing, the draft amendment to the Drug Administration Law (“Amendment DAL”) was submitted for a second review, and below key amendments are announced and discussed:

• Strengthen the regulation of internet drug sales: Any third-party online platform for drug-selling to be filed with government, qualification examination is required to be done. Prescription drugs shall not be sold directly through any third party online platform.
• Inflated drug price and drug shortage are two typical problems in China in the past, the further amendments of the DAL mentions that government shall strengthen the drug prices monitoring work, and relevant departments under the state council may take appropriate measures in the drug production, price intervention and organizing drug importation to prevent and mitigate the drug shortage issue.
• Further clarify the responsibilities of Marketing Authorization Holder(MAH) in the entire life cycle. Marketing authorization holder shall be responsible for the whole process from non-clinical research to clinical trials, production to marketing and post-marketing monitoring for any adverse reactions. Moreover, the holder shall sign an agreement with the enterprise entrusted to produce, market, store and transport the drug, ensure the service quality and risk management ability.
• Encourage pharmaceutical clinical value-oriented innovations, accelerate the review and approval of clinical-needed innovative drugs, especially for anticancer drugs, children’s’ drugs, and orphan drugs. Moreover, as the key to drug development, clinical trials should be conducted complying with ethical principles. In the draft amendments, it further clarifies the ethics committee’s responsibilities to fully protect patients’ right to know and right to choose during clinical trials, which mean all risks should be truthfully stated to patients, patients’ consent should be obtained.

It is worth noticing that although the draft revision of the Drug Administration Law has not yet passed and will be further discussed on the next deliberation of the NPC. However, the cancellation of compulsory GMP and GSP certification, the establishment of Marketing Authorization Holder(MAH) system, the implementation of whole-process supervision, and the strengthening of penalties for drug-related violations have become recognized reform directions in and out of the industry, which will lead to fundamental changes in China’s drug regulatory path, as well as huge changes in the way the industry develops.