UK MHRA will not act as ‘leading authority’ for medicines during the Brexit transaction period as per Article 123 of the draft Withdrawal Agreement. In which UK MHRA will not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States. (more…)
FDA to implement all COVID-19 related guidance immediately, without public comment. But will open for public comment after implementation and FDA said it will still solicit comment, review all comments received and revise the guidance documents as appropriate. (more…)
The FDA issued new guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. (more…)
Albania entered in to the member state of European Pharmacopoeia as 39th member on 9 February 2020, making the quality standards for medicines published in the European Pharmacopoeia (Ph. Eur.) legally binding throughout the country. (more…)
Swissmedic and the Korean regulatory authority extend their cooperation in the area of therapeutic products by recognizing each other for GMP Inspections. (more…)
The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission (EC) have published Key principles outlining a harmonised approach to develop and use of ePI – electronic product information. (more…)
The World Health Organization’s vision towards strengthening the regulation of medical products in underserved regions, the WHO published a draft policy on Designating Regulators as Listed Authorities (WHO-Listed Authority) to establish a framework for ensuring certain medical product regulators can be globally recognized as meeting WHO and other international standards and practices. (more…)
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing. (more…)
Prospective abbreviated new drug application (ANDA) applicants will be able to submit Pre-Assigned ANDA number requests via the CDER NextGen Portal.
For Applicants with account holder account will be automatically updated with this Pre-Assigned ANDA number request functionality. To create a new account, go to the CDER NextGen Portal, under the “Sign In” section on the right of the screen, click “Sign Up” (next to “Don’t have an account?”) and follow the instructions. (more…)
The US Food and Drug Administration (FDA) finalized guidance on conducting maximal usage trials (MUsT) to support the inclusion of an active ingredient in an OTC monograph. (more…)