Regulatory Blog

On 28 September 2022 Swissmedic updated and released their "Guidance document Medicinal product name HMV4 ". This guidance document...

Yesterday (29-September 2022) Health Canada updated their guidance on Regulatory Enrolment Process (REP). Health Canada's Regulatory...

Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of...

Earlier today (30 September 2022) to ensure British people have timely access to medicines, the European Commission Decision Reliance...

Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...

USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022). 1. Guidance on: Clinical Performance...

Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...

Earlier today (27 September 2022) MHRA released updated guidance on Good clinical practice for Clinical Trials where they had updated...

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...

This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...

Yesterday (22 September 2022) USFDA issued “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act...

Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...

The UK MHRA released this updated guidance today and added a section on 'Advertising and promotions' to Northern Ireland MHRA Authorised...

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal...

Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...

Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...

Recently the Pharmacopoeial Discussion Group (PDG), which comprises the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia...

In yesterday's final rule, the U.S. Food and Drug Administration outlined (Unpublished version) the requirements for annual reports by...

The Register of Innovative Drugs is maintained pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations of Health Canada and...