On August 26th, 2019, China’s top legislature voted to adopt the revision to the drug administration law, which is an update from the version in the year of 2001.
In the updated drug law, the concept of marketing authorization holder (MAH) is officially introduced for the first time in China. Although the MAH system is not new to the rest world, it is new for Chinese pharmaceutical companies to completely detach the license holding from the manufacturing, i.e. the license holder of a drug within the country may assign a manufacturer for the production, rather than setting up the whole manufacturing chain by itself. This MAH system shall largely encourage the drug innovation by reducing the investment from market to production.
To promote the technical innovation and fulfill the clinical needs of new drugs, the new imported drugs are not required to receive the approval in the home country. It is certainly a great news for overseas companies to plan China as one of the countries in the first tier for new drug launch. This would encourage the global pharmaceutical companies to run the multiple regional clinical trials (MRCT) with China included. In this way, the Chinese doctors and industry may get more chances to work on the most advanced technology in the world. The approval for allowing a clinical trial in China is also changed into the 60-working-days notification, which further accelerates the MRCT preparation process and makes the product approval in China easier.
It is also worth to mention that the updated drug law has emphasized that the pediatric drugs can be approved with priority. The NMPA has been publishing the list of pediatric drugs for fast approval on its website.
The pharmacovigliance is also of importance in the update drug law. The Chinese authority has urged the MAHs to set up the PV sytem to track the drug in the full life cycle.
Moreover, the regulations about drug sold online are also introduced for the first time. The online drug store shall be responsible for the quality of the drugs sold on its platform.
The revised drug law is effective from December 1st, 2019.
For full text in Chinese, please go to this link: Drug administration law on August 26th, 2019。