March 15, 2024
The Chinese pharmaceutical landscape is constantly evolving, with new regulations and drugs emerging regularly. While keeping up with these changes can be challenging, remaining updated is crucial for businesses operating in the Chinese market.
Here, we bring you five (05) of the most important pharmaceutical Regulatory updates in China that have been released in 2024.
1. Tighter Regulations for Outsourced Manufacturing
The National Medical Products Administration (NMPA) is raising the bar for drug Marketing Authorization Holders (MAHs) who outsource their manufacturing processes. This move aims to improve drug quality and safety by imposing strict oversight and control over outsourced operations. MAHs outsourcing manufacturing will now have to be prepared for more stringent inspections and documentation requirements.
2. ANDAs under Scrutiny
The NMPA is contemplating disallowing Abbreviated New Drug Applications (ANDAs) for generic drugs that lack Reference Listed Drugs (RLDs) and offer no substantial clinical value as compared to existing treatments. This policy aims to encourage innovation and development of novel drugs and, in turn, gives a boost to real innovation rather than simple replication of existing options. Thus, companies planning to submit ANDAs in China should carefully consider this criterion and ensure that their generics offer meaningful clinical advancements.
3. Improving Paediatric Medication Information
The NMPA has released guidelines for adding pediatric medication information to the labels and instructions of already authorized drugs. This crucial step specifically aims to enhance the safety and efficacy of drug use in children. Manufacturers will now have to review their existing drugs and, where applicable, conduct studies or submit data to support the inclusion of pediatric information on the respective labels.
4. An Innovative TCM Product Gets the Greenlight
Ercha Shangqing Wan, a Category 1.1 innovative Traditional Chinese Medicine (TCM) product, has received marketing approval from the NMPA. This approval showcases the growing Regulatory support for the development of innovative TCM products.
5. Conditional Approval for CAR T Cell Therapy
Equecabtagene Autoleucel Injection, a CAR T cell therapy, has been granted conditional approval for the treatment of specific types of leukemia. This conditional approval highlights the NMPA’s commitment to facilitating access to promising new therapies while ensuring patient safety through post-approval monitoring.
These are just a few key updates shaping the Chinese pharmaceutical landscape in 2024. Staying informed about these changes is crucial for businesses operating in the market and willing to enter the market to ensure compliance, navigate the Regulatory environment, and seize opportunities presented by evolving policies.
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