Regulatory Blog

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with...

India's Ministry of Health and Human Welfare has released a draft proposal on 14th June, 2022 which suggests to add barcodes or quick...

Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...

FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...

Health Sciences Authority (HSA) updated its "GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE" recently, which describes the...

Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance Medicinal products with known...

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...

The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial...

The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

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...