Overview:

China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers. 

New Drug Review Process:

According to the regulation, NMPA initiated new drug review process that is much like the United Sates’s FDA review process. The NMPA has divided the approval process into the following categories:

  1. Breakthrough
  2. Priority review
  3. Fast-track approval
  4. Special approval process

Timelines:

Generally,the drug approval process in China can take up to 3 years, However the newly introduced fact track approvals can reduce the approval process to 16 months.

Facilitated Generic Drug approval Process:

 If the following drug categories have previously been approved and marketed in United States, European Union or Japan in the past 10 years and not yet been approved in China they are eligible for the  breakthrough, priority, fast-track or special designation for approval: 

  1. Rare disease treatment
  2. Life-threatening disease for which no treatment is available
  3. Drugs that are used for the treatment of life-threatening disease and outweighs clinical advantages than the already existing drugs in the market

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

More Resources:

China’s NMPA

 

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