Update in Drug Regulation in China – Revocation of GMPc Requirements

On August 26, 2019, the Standing Committee of the National People’s Congress of China passed the Amended Drug Administration Law, effective December 1, 2019.

Some changes are of major importance and may directly impact the pharmaceutical industries. Below, the most relevant changes.

Revocation of the requirement for Good Clinical Practices (BPC), Good Distribution Practices (BPD) and Good Manufacturing Practices (GMP)

The update revokes the BPC, BPD, and GMP certification requirement. Thus, clinical institutions, distributors and medicinal products manufacturers will no longer be subject to mandatory certification.

National and local inspections conducted by the National Medical Products Agency (NMPA) on medicinal products distributors and manufacturers may occur to ensure continued compliance, but it is not entirely clear how clinical trial institutions will ensure their self-compliance with GCP requirements and whether NMPA would conduct inspections of such institutions at the same level of depth.

Prescription medicinal products online sales

The update suspends current restrictions on online sales of prescription medicinal products. Except for vaccines, blood products and other high-risk medicinal products under special control, prescription medicinal products may be sold online by marketing authorization holders (MAHs), medicinal products distributors and third-party e-commerce portals.

The MAHs System

With the approval of the Amended Law, the MAH system will be implemented nationwide, presumably after the completion of the current pilot program in selected regions of China. The MAH system allows the separation of MAH from actual manufacturers, except for certain high-risk products such as vaccines. Marketing authorization will be transferable, subject to approval by NMPA (National Administration of Medical Products).

Revisions to definitions of counterfeit and inferior medicinal products

After more than 10 years of research and debate, definitions of counterfeit and inferior medicinal products have been revised.

The definition of a counterfeit drug becomes narrower, including (i) a medicinal product that contains ingredients which do not comply with national drug standards, (ii) a non-medicinal product being sold as a medicinal product or a medicinal product being sold as another medicinal product, (iii) a deteriorated medicinal product or (iv) a medicinal product labeled with unapproved indications.

On the other hand, the definition of inferior medicinal product is expanded to include (i) drugs with noncompliant quantity of ingredients, (ii) medicinal products with noncompliant shelf life or batch number, (iii) drugs with unauthorized expedients or (iv) medicinal products which are otherwise noncompliant with the applicable national standards.

Increased Penalties

The Amended Law significantly increases the level of administrative penalties, especially monetary penalties, for various violations. For example, manufacturing and selling counterfeit medicinal products, inferior or unapproved medicinal products, and / or making unauthorized changes to the product manufacturing process can result in a monetary penalty of 15 to 30 times the values of the product.

The full text on the news can be accessed through the link: https://bit.ly/2r9YVNy.

Count on Vita to conduct your regulatory projects in Europe and Latin America.