Does the production process of gelatin hollow capsules need national approval?

Gelatin hollow capsules belong to drugs, and the production of drugs needs to obtain the national approval number, which is a necessary condition. In order to obtain the approval number, the production process must be clearly specified in the relevant materials. Once there is a major change in the production process, it must be reported, and the products produced by the new process are qualified for inspection. As for the small links and methods of production technology, enterprises have the right to adopt more advanced, more scientific, more energy-saving and more environmentally friendly methods on the premise of ensuring product quality. This is the competitiveness of enterprises, and no department has the right to interfere and does not need to apply for approval. Enterprises with creativity and innovation can also apply to the State Patent Office for patent protection.