Maximal Usage Trials Guidance for Topical OTC Drugs Finalized By FDA

The US Food and Drug Administration (FDA) finalized guidance on conducting maximal usage trials (MUsT) to support the inclusion of an active ingredient in an OTC monograph. (more…)

Two more countries Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for inspections

The US Food and Drug Administration (FDA) confirmed the capability of two additional European Union (EU) Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019.

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TGA Announced Labelling changes: information for health professionals

Quality Use of Medicines relies on clear medicine labels. To reduce medication errors, medicine labels need to be more consistent, with important information made more prominent and easier to read.

Therapeutic Goods Administration has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice and are designed to be more consistent and more clearly convey important information. TGA thinks these changes may reduce medication errors.
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FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths.

These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.
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FDA Upgraded Website on 29th April 2019

After three years in the works, the US Food and Drug Administration launched redesigned and more customer-centric website at FDA.gov. “April 29 is the official launch date”.

The new Food and Drug Administration website, which the agency said receives nearly five million visitors each month, will provide the public with health and safety information that is easier to locate and navigate. The spokeperson noted that between approximately 30,000 pages to 40,000 files make up the redesigned FDA.gov site.
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ICH Q12 – Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

A draft version of ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) was issued in November 2017, and the goal is to have a final version by November of this year.

A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the biopharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.
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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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