Regulatory Blog

The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting...

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...

USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....

Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry...

On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...

Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products....

Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...

Pakistan's Drug Regulatory Authority (DRAP) has finalized its guidelines for imports and exports of therapeutic goods. This document...

This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...

US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...

The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...

Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...

On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...

Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...

On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...

The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...

On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...

The Health Products Regulatory Authority (HPRA) updated its guidance on "Parallel Imports of Human Medicine" last week. Parallel...