Data Requirements for Human Drug Submission updated version 2.1 for GCC CTD

New Guideline Data Requirements for Human Drug Submission updated on 24-October-2017 Version 2.1 for GCC CTD. The Saudi Food and Drug Authority (SFDA) has updated its Gulf Cooperation Council (GCC) data requirements for human drugs submission. The data requirements for each application will differ, depending on the drug submission type and all the required data should be in accordance with the CTD structure.

Generic Drug User Fee (GDUFA): Proposed Changes for 2018

Generic drug user fee makes it possible for FDA and industry to ensure that the public has access to safe and high quality generic drugs and drug products.

The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. Generic drug user fee act was reauthorized on August 18, 2017 (GDUFA II), with provisions that go into effect from October 1, 2017 and remain in effect through September 30, 2022.

EU and Swiss regulators sign confidentiality arrangement

The European Medicines Agency (EMA) and the European Commissions Directorate General for Health and Food Safety (DG SANTE) have agreed with the Swiss Agency for Therapeutic Products (Swissmedic) and the Swiss Federal Department of Home Affairs (FDHA) to share non-public information on the safety, quality and efficacy of medicines, already authorised or under review, both in Switzerland and in the European Union (EU) in order to enhance public health protection.


FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates

The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2015.