Tag: EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
EMA serves a market of over 500 million people living in the EU.

EMA’s Guidance to Avoid Presence of Nitrosamine Impurities in Human Medicines Expected

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised act...

CVMP Recommends Authorisation of Two New Vaccines

vaccine
The Committee adopted by majority a positive opinion for an initial marketing authorisation application for Gumbohatch, from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of 1-da...

European Parliament’s ENVI Urges to Give EMA More Money and Staff

The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety,...

PRAC Starts Review of Data on Skin Cancer with Picato

european medicines agency
EMA’s safety committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunligh...

EMA Published Two Guidances on Drug Shortages

Regulators in the European Union have taken the first steps to diminish shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two gui...

Draft ICH Guideline on Clinical Trials Discussed at EMA

clinical-trials
The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical...

EMA Offered Comments and Edits on FDA Draft Guidance on Biosimilars

biosimilars
Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late last month offered line-by-line comments and edits on a recently released dra...

Viralgen Received EMA cGMP Compliance Certification

Viralgen has received current Good Manufacturing Practices (cGMP) compliance accreditation and Pharmaceutical Laboratory authorization by the AEMPS (Spanish Agency for Medicines and Health Products) a...

EMA Recommended Measures to Prevent Serious Errors with Methotrexate for Inflammatory Diseases

EMA
EMA has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s ...

EMA Extended Licence for Mundipharma’s Invokana

european medicines agency
Mundipharma has announced that the European Medicines Agency has accepted the license extension submission for Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) to treat stage two o...

Biocon Received Certificate of GMP Compliance from EMA

biocon
Biocon Ltd, Asia’s premier biopharmaceuticals company, announced that it’s subsidiary in Malaysia, Biocon Sdn. Bhd., which operates Asia’s largest integrated Insulins facility, received the Certificat...

High Degree of Alignment in Marketing Application Decisions Confirmed by EMA/FDA

EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorization decisions for new medicines.  This is one of the findings of a joint EMA/FDA analysis compa...

Gilead Sciences Announced EMA’s Marketing Application for Filgotinib

Gilead Sciences, Inc. and Galapagos NV announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with...

EC Reminded about Batch Testing Transfer of Medicinal Products after Brexit

From today’s perspective, the UK will be a third country as of 1 November 2019. As a result, all batch testing facilities will have to be fully transferred to the EU27/EEA by 1 January  2020. T...

EMA Requested to Change Names of Liposomal Medicines to Avoid Medication Errors

ema
All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to EU regulators a variation to change the names of these medicines as soon as possi...

ProQR Therapeutics’ Sepofarsen Granted Access to PRIME Program by EMA

ProQR Therapeutics N.V., a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, announced that its sepofarsen (QR...