Pharma Specialists

EMA

Stability Testing for Marketing Authorisation Variations

The EMA has released a revision to the Guideline on stability te…

December 15, 2025

EMA

Plasma Master File Certificates | EMA Regulatory Update

The plasma master file (PMF) is a compilation of all the require…

January 14, 2024

EMA

First Electronic Product Information (ePI) Published for Selected Hhuman Medicines

The Heads of Medicines Agencies (HMA), the European Commission…

November 10, 2023

AI

The Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle | EMA Reflection Paper

Data are generated and used increasingly across sectors, includi…

August 07, 2023

Clinical Trials

GCP Guideline on Computerized Systems and Data Integrity

Following the draft guideline published in June 2021 the final E…

June 18, 2023

EMA

EMA Risk Management Plan

Companies are required to submit a risk-management plan (RMP) to…

November 15, 2022

EMA

Clinical Study Reports Submission on EMA | A Quick Guide

Where a clinical trial is intended to be used for obtaining a ma…

October 30, 2022

EMA

Questions and Answers on Nitrosamine Impurities for Marketing Authorization

EMA Updates on nitrosamine impurities along with Questions and a…

October 16, 2022

EMA

Excipients in the Labelling and Package Leaflet | EMA Guidance

This document is an annex to the European Commission guideline o…

September 19, 2022

DMF

European Drug Master File (EDMF)

European Drug Master File (EDMF) also known as Active Substanc…

June 17, 2022

Contamination

Nitrosamines in Herbal Medicinal Products | Regulatory Compliance

The EMA Committee on Herbal Medicinal Products (HMPC) has prepar…

February 10, 2022

Bioequivalence Study

USFDA/EMEA/CANADA/Japan/WHO guidelines on BioEquivalence (Part-3)

Study Population Criteria for BE study population: Min. of 12 su…

October 09, 2021