Regulatory Blog

On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...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

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On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...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

A new how-to guide was published by the International Pharmaceutical Excipients Council (IPEC) to assist the pharmaceutical industry in...

On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the...

Guideline on Good Pharmacovigilance Practices (GVP) for Pregnancy Prevention Programs A public consultation was launched by the European...

This guidance document describes the rules that apply to the renewal or discontinuation of authorisation, how these rules are to be...

The MHRA on 17-March-2022 updated its Guidance on Advertise your medicines which details how to comply with the requirements on promoting...

Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...

On 11-March-2022, SwissMedic released updated guidance on "Packaging for Human Medicinal Products". The purpose of this document is to...

Project Orbis aims to review and approve promising cancer treatments to help patients access treatment faster. MHRA recently added...

As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...

The purpose of this document is to inform applicants on how to submit variations to the South African Health Products Regulatory...

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