Regulatory Blog

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...

On 11-March-2022, FDA released the final guidance "Providing Regulatory Submissions in Electronic and Non-Electronic 1 Format —...

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...

On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...

Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...

The Health Products Regulatory Authority (HPRA) Ireland released updated guidance on the "Guide to Wholesaling and Brokering of...

1. Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR This guidance is intended to provide information to applicants...

FDA is issuing this draft guidance "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance...

As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...

MHRA, the UK Medicines and Healthcare Products Regulatory Agency has updated its guidance information on the Innovative Licensing and...

On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...

On 1-February 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP)...

Irelands HPRA released a few guidances in the past week Guide to New Applications and Variations to Manufacturer's Authorisations This...

FDA published a series of guidances on January 26, 2022 focussing on Generic Drug Application Submissions, Labeling, and Review. These...

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and...

UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...

Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...