Drug registration is a highly professional job, which requires the drug registrar to cover many fields such as pharmacy, pharmacology, pharmacy, biochemical pharmacy, etc., and generally requires a postgraduate degree or above in pharmacy.
In addition to being familiar with the Drug Administration Law and the Measures for the Administration of Drug Registration, it is also necessary to have a full understanding of other relevant and even non-drug legal provisions, such as the Measures for the Administration of Drug Import and the Law on the Protection of Intellectual Property Rights. Good communication and coordination skills.
Extended data:
The State Administration of Pharmaceutical Products may implement rapid examination and approval of the following new drug applications:
1, a preparation made of medicinal substances such as plants, animals and minerals that have not yet been marketed in China, as well as effective components extracted from traditional Chinese medicines and natural medicines and their preparations;
2. Chemical APIs and their preparations and biological products that have not been approved for listing at home and abroad;
3. Anti-HIV and new drugs for diagnosing and preventing AIDS, and new drugs for treating malignant tumors and rare diseases;
4. New drugs for diseases that cannot be effectively treated.
Baidu encyclopedia-medicine registration Commissioner