The Active Pharmaceutical Ingredient (API) is the part of any drug that prod uces its effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.
Finished drug formulation(FDFs) is made to cure medical symptoms. Different form can have totally different effect. The original formulations always take years of hardwording and tons of money to invest.
Pharmaceutical intermediates are used in the compound process for APIs. Usually intermediates do not request for manufacturing permit, normal factories are also able to provide intermediates.
In recent years, China's pharmaceutical regulatory system has undergone major changes, with the aim of achieving the effects of management jump, concept renewal and technological progress, which has led to close study and exchange between the Chinese pharmaceutical industry and the foreign pharmaceutical industry.
As the masses of Chinese people are increasingly demanding high-quality and reasonably priced medicines, new policies are being continuously promulgated, piloted and implemented, which is an opportunity for imported preparations to be more concerned and valued. The root cause is roughly divided into three points.
Since the reform and opening up, with the continuous advancement of medical technology, China's drug review standards have been continuously improved. Past drug review standards have not mandated that generic drugs are consistent with the quality and efficacy of original drugs, so some drugs have certain efficacy and original drug.
The year of 2019 is the 40th anniversary of our country's reformation. During this time, Chinese pharmaceutical market has managed to achieve a huge scale-up. The philosophy of every pharmaceutica
General PrinciplesApplication for Drug RegistrationPre-clinical Laboratory Study of DrugsClinical Study of DrugsApplication and Approval of New DrugsApplication and Approval of Drugs Already withNatio
Requirements for application documents of registration category 4 and 5.2 (trial implementation) I. Items of application documents(I) Summary1. Name of the drug2. Certificates2.1 certificates req
I. Items of application documents(I) Summary1. Name of the drug2. Certificates2.1 certificates required for category 1, 2, 32.2 certificates required for category 5.13. Purpose and basis of the projec