In the wake of the massive recall of a hypertension drug last year, South Korea is stiffening its control of pharmaceutical safety. Beginning immediately, the country's primary regulatory body, the Ministry of Food and Drug Safety (MFDS), is mandating manufacturers of raw drug materials disclose any potentially hazardous substances contained in their products while seeking drug approval and registration.
MFDS inspectors will also conduct random inspections of pharmaceutical products and, in the case of drugs manufactured in South Korea, the physical plants where they are produced. The ministry also plans to revise the Korean Pharmacopoeia, a set of instructions on drug handling for drug manufacturers produced by the government, to meet international standards.
Under the new guidelines, consumers who suffer adverse reactions from the use of pharmaceuticals registered with and approved by the ministry will receive increased compensation.
About Pacific Bridge Medical
Pacific Bridge Medical (PBM) was founded in 1988 to help international medical companies solve their most complex problems while doing business in Asia. Since then, PBM has assisted hundreds of healthcare companies with business development and regulatory issues in Asia. We provide our services to all types of medical firms, including medical device, IVD, pharmaceutical, and API.------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------