Making Submissions Related to Human Medicines to the MHRA in a No Deal Scenario

MHRA sets new process for Pharma Submissions if UK leaves the EU in a no deal scenario. Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU in a no deal scenario.

The MHRA is making preparations to ensure that in the event they leave the EU with no deal, you can continue to submit regulatory and notification information to the UK

Before getting started – guidance
Three short video demos are provided below which cover all aspects of the user access management process – these steps will enable your organization to gain access and manage user permissions for using MHRA Submissions.
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Electronic product information (ePI) for human medicines in the EU

On 31 January 2019 the European Medicines Agency (EMA) published draft key principles for the development and use of electronic product information (ePI) for medicines for human use in the EU. Stakeholders and members of the public can submit comments using an online form until 31 July 2019.

The European Commission, HMA and EMA are working together to facilitate the development of electronic tools to improve access of patients and healthcare professionals to product information in the EU. Electronic formats bring new opportunities for summary of product characteristics and package leaflets.

For more detailed information on draft key principles for ePI refer below link.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-draft-key-principles_en.pdf

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.

https://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx

Generic Drug User Fee (GDUFA): Proposed Changes for 2019

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.
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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.

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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.

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