What is the Government-Set Profit Margins(%) for drug types in China?

1. Synthetic drugs

• Drugs not included in the classification of new drugs or outside the new drug protective period: 15% for bulk substances; 8% for preparations;
• Ordinary drugs manufactured by enterprises that have attained the Good Manufacturing Practice (GMP) standard, or have been certified by the Chinese Drug Attestation Committee (CDAC) and acquired a GMP certificate (in the first 3 years): 15% for bulk drug substances; l l % for preparations;
• Bulk drugs and preparations for drugs that fall within the protective period of patents conferred in the country where discovery took place: 30%. Bulk drugs approved for manufacturing as Class IV new drugs: 30%; their materials: 20%; Drugs outside the protective patent period: same as Class IV new drugs;
• Drugs used in emergencies, detoxification, cancer treatment, anaesthesia, psychosis, contraception, regional diseases, and other special uses outside the protective period: bulk, 20%; preparations, 15%.

2. Traditional Chinese medicines (TCMs)

• TCM preparations manufactured by enterprises with GMP accreditation: 23%; certified by CDAC: 15%;
• TCM preparations produced within the protection period of a patent 20%; those produced outside the patent protective period: 30%;
• Well?established, branded TCM products should be allowed an appropriate price premium over other drugs in the same category;
• The profit margin for TCM products for export and tourism is unrestricted.

3. Biological drugs

• Products that are not included in the new drug classification or outside the protective period for new products: 20%;
• Ordinary biological products manufactured by enterprises that have attained the GMP standard and have been certified by CDAC and acquired a GMP certificate (in the first 3 years): 23% for hulk drug substances; 15% for preparations;
• Biological products produced within the protection period of a patent: 35%;
• Those produced outside the patent protection period: 30%.

4. Biochemical drugs

• Drugs not included in the classification of new drugs, or outside the new drug protection period: 12% for bulk substances; 8% for preparations;
• The profit margins of ordinary biochemical drugs, manufactured by enterprises that have reached the GMP standard, have been certified by CDAC, and acquired a GMP certificate (in the first 3 years): 15% for bulk drug substances; 11 % far drug preparations.