Regulatory Blog

The Singapore Health Sciences Authority (HSA) published a Safety Alert for Finasteride on 30-August-2022. Suicidal ideation is a known...

On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...

On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...

In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...

On August 23, the Saudi Food and Drug Authority updated its "Guidelines for Stability Testing of Active Pharmaceutical Ingredients and...

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...

On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...

Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...

Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence" The guidance in general details...

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...

Today (9 August 2022) MHRA updated their Guidance on Clinical trials for medicines to manage authorisation, and report safety issues. The...

Recently the National Institute for Food and Drug Surveillance - Invima and the United States Pharmacopeia - USP, celebrated the signing...

Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...

Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This...

Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...

Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products...

Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...