Asia Rounds Up Regulations, To Adopt 10 EMA Guidelines

By Czarina Ara Lasco

Oct 07, 2016 06:00 AM EDT

After declaring its plan on adopting 10 European Medicines Agency (EMA) guidelines, the Therapeutic Goods Administration (TGA) of Australia is seeking feedbacks and recommendations. Among the contexts of the said guidelines includes substitutes for the current EMA texts previously adopted by TGA. Some of the documents such as guidelines on clinical development of drugs against Duchenne Muscular Dystrophy (DMD), however, will be included in the new set of additions.

Among the texts up for adoption by TGA which speak about clinical advancement is EMA's DMD guideline. It took 30 months for DMD guideline to go from the beginning of the initial consultation to the agreement on a final draft, making it one of the more conspicuous texts in a set of guidance documents which cover clinical trials in amyotrophic lateral sclerosis, asthma and other indications, as well. All the other clinical trial guidelines TGA considers adopting, aside from the DMD text, are alternatives for the previous documents from EMA.

The use of pharmacogenomics methodologies when carrying out pharmacovigilance evaluations is one of the entirely new guidelines which will be used by TGA. The said guideline came into action in the EU on April 1 to provide the industry with an overview of how genomic biomarkers that influence how a particular person's respond to a drug can factor into pharmacovigilance activities and product labelling. This quality of the said guideline also makes it the oldest of the documents set for adoption by TGA. TGA considers that the correlation between summaries of product characteristics and its own product information would only mean its possibility to adopt the text.

TGA is accepting comments and suggestions on its plan for the adoption of the 10 EMA guidelines until 9 November.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

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