Answer: If the chemical substances contained in the additives are not included in the IECSC and belong to new chemical substances, they should be registered in accordance with the "Measures for the Environmental Management and Registration of New Chemical Substances".
Answer: API manufacturers need to meet the GMP supervision and management requirements of drugs, whether they are exported or sold domestically. Enterprises need to determine whether they meet the exemption conditions, and the supporting documents provided can withstand verification. In the case of export only, the certificate of API exported abroad is acceptable.
Answer: The Guidelines for the Registration of Environmental Management of New Chemical Substances clearly point out that the Measures are not applicable to pharmaceuticals (including APIs), pesticides (including pesticide ingredients), veterinary drugs (including APIs), cosmetics, food, food additives, feed, feed additives, fertilizers, etc. However, if the above-mentioned products are changed to other industrial uses, as well as the ingredients or intermediates used in the production of the above-mentioned products, which are new chemical substances, the Measures shall apply.
Answer: No, It is necessary to go through the notification or registration in accordance with the requirements of the "Measures for the Environmental Management and Registration of New Chemical Substances".
