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5 days ago2 min read

South Africa-SAHPRA: Engagement Portal

As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...

Jun 52 min read

EMA Guidance: IRIS Guide for Applicants

On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...

Nov 27, 20221 min read

Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland

On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...

Nov 16, 20221 min read

Irelands HPRA MD Guide: Performance Studies Conducted in Ireland

Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to...

Nov 12, 20221 min read

USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs

Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...

Jun 7, 20221 min read

EMA- New Guidance on Complex Clinical Trials

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

May 26, 20221 min read

USFDA- Q&A Guide on Importation of Prescription Drugs from Canada

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

Mar 30, 20221 min read

Guide to Wholesaling & Brokering of Medicinal Products - Ireland

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

Mar 30, 20221 min read

Guide on Microplastic Usage - IPEC Europe and IPEC-Americas "How to Document"

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