Regulatory Affairs Blog

Proposed Guideline on LMWHs in Biosimilars

Mon, 05 Aug 2013 16:22:00 GMT

The European Medicines Agency (EMA) announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs), a type of medical product often used...

Regulatory Affairs Vs Regulatory Sciences

Thu, 20 Jun 2013 11:53:00 GMT

Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical...

API GMP Requirements Update

Mon, 29 Apr 2013 11:49:00 GMT

In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International...

Biosimilars Sector from EU and US Perspectives

Tue, 26 Mar 2013 12:10:00 GMT

Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly...

Asia's Changing Regulatory Environment and Pharma Outsourcing

Mon, 14 Jan 2013 14:45:00 GMT

Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention...

Extractables, Leachables and QbD

Tue, 20 Nov 2012 17:29:00 GMT

Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated...