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Press Releases, Latest News, Updates

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes,1 cardiovascular disease,2 and infectious disease.3 Within the last two decades, the U.S. Food and Drug

By |2020-04-01T12:48:36+01:00March 3rd, 2014|Regulatory Affairs|0 Comments

A WHO Guide to Good Manufacturing Practice (GMP) Requirement

This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by Good Manufacturing Practices (GMP) of the World Health Organization

By |2020-04-01T12:48:36+01:00April 19th, 2012|Quality assurance|0 Comments

Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure. Until further notice, the applications considered will be those for solid oral dosage forms

By |2020-04-01T12:48:36+01:00February 8th, 2012|Regulatory Affairs|0 Comments

PIM – Innovative Solution for Ensuring Consistent and High-Quality Product Information

EMA (ex EMEA) is performing a pilot phase of what is known as a Product Information Management system (PIM). It is about interactive IT interface for the submission, review and

By |2020-04-01T12:48:36+01:00December 30th, 2010|Regulatory Affairs|0 Comments
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