Regulatory Affairs

In June 2018, N-nitrosodimethylamine (NDMA) and similar compounds known as nitrosamines, classified as probable human carcinogen based on animal studies, were unexpectedly found in several blood pressure medicines known as sartans leading to some recalls and resulting in new manufacturing requirements and stricter limits for nitrosamines for these medicinal products. Traces of NDMA have also been found in the active substance pioglitazone hydrochloride; however, considering that the levels of this impurity were within the temporary limits set after the review of sartans, no action was taken about the products on the market. In September 2019, EMA started an EU-wide review of ranitidine medicines after tests showed that some of these products too contained the impurity NMDA. Considering the above-mentioned events, as a precaution, the Committee for Medicinal Products for Human Use (CHMP) asked to all Marketing Authorization Holders (MAHs) to review the medicinal pro

Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials are now reviewed/approved as part of a drug product application. Before called CFDA, now the National Medical Products Administration (NMPA) had a pre-market approval policy that allowed APIs, excipients and packaging materials to be registered separately with pharmaceutical product application. The process usually took longer and was more expensive. The new system allows these manufacturers to file the DMF reducing the approval time and respective cost involved. Pharmaceutical manufacturers can refer to the DMF code while submitting the drug application making the process more efficient. Who Can File a Drug Master File (DMF)? The following category of companies inden