China slaps MAH system on vaccine manufacturing to limit newcomers
Minhua Chu ·08/01/2022
Regulatory


China is set to implement a strict access system for vaccine manufacturing to limit the entry of new vaccine manufacturers, according to a new rule released by the NMPA on July 11 that took effect immediately.


The new Regulation on Vaccine Production and Distribution clarifies that the marketing authorization holder (MAH) system will apply to vaccine production. The system has already been in place for those producing drugs and medical devices.


But the MAH system for vaccines will work differently. Unlike marketing authorization holders for drugs and medical devices who can outsource manufacturing to a third party, vaccine makers are required to have their own manufacturing capacity.


Only when their capacity cannot meet the number of doses proposed by the Ministry of Industry and Information Technology and the National Health Commission (NHC) can they outsource production to a third party. Another exception is when they need to produce multi-disease or multivalent vaccines.


The scope of entrusted production should cover the entire process of vaccine production. If necessary, the entrusted production of multi-disease and multivalent vaccines may be for the vaccine stock solution or production preparation stage, subject to NMPA approval. 


Vaccine manufacturers engaged in export are required to only sell the vaccines abroad and not in China.


Vaccine startups face more challenges


The pandemic has prompted many biotech companies in China to focus on vaccines. Aside from the seven COVID-19 vaccines that have obtained conditional approval or EUAs, there are dozens more in development.


PharmaDJ found 20 COVID-19 vaccines in development by Chinese companies. However, only seven drugmakers have obtained the production license.



Most of the vaccine developers with a candidate in early clinical development have not obtained production licenses. Out of the eight home-grown mRNA vaccines, only Abogen has the production license.


With the Chinese government tightening the new production licenses for vaccines, vaccine developers are facing more challenges in pushing their products to the market, especially startups.


Selling vaccines to the CDC


Under the regulation, marketing authorization holders for vaccines can only sell their vaccines to the Chinese Center for Disease Control (CDC) via distributors with appropriate qualifications and capabilities. One holder cannot have more than two distributors in one province.


Foreign marketing authorization holders for vaccines should designate a Chinese distributor with cold chain capabilities to sell their vaccine products.


Electronic tracing system


China’s NMPA and NHC will establish a national electronic tracing system for vaccines to ensure their safety.


All the information on the sales, transportation and use of vaccines are to be recorded, so that the entire process of production can be traced back based on the minimum packaging unit.


Regular inspections and AE reports 


The NMPA will conduct at least one inspection on the marketing authorization holders for vaccines every year, while their provincial counterparts will inspect the holders and their manufacturers at least twice a year.


The new rule also stipulates that if suspected adverse reactions or group adverse events are reported, the NHC will send experts to investigate if they are related to the quality of the vaccines. Any vaccine quality and safety issues that can threaten public health would be handled in accordance with the emergency plans of the local government.


Keywords: vaccine China slaps MAH system NMPA new rule
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