WebMerck KGaA, Darmstadt, Germany. Feb 2012 - May 20153 years 4 months. Singapore. • Head of Regulatory Affairs for Merck Biopharmaceutical and Consumer Healthcare in Singapore and Brunei ($25 million). • Responsible for prompt regulatory approval and full compliance of 90+ medicinal and device product licences across General Medicines …

Market Approval Process for Generic Drugs in Brunei

WebI. BACKGROUND. In 2005, the Department of Health (DOH) – Food and Drug Administration (FDA), then Bureau of Food and Drugs (BFAD), has adopted and implemented the Association of Southeast Asian Nations (ASEAN) Harmonized Cosmetic Regulatory Scheme and the ASEAN Common Technical Documents, including the … WebApr 14, 2024 · US District Judge Matthew Kacsmaryk's ruling that suspended the US Food and Drug Administration's approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market. fishbecks patio center

MEDICINES REGISTRATION HARMONISATION IN AFRICA

WebApr 2, 2024 · Drug Regulatory Authority • The drug regulatory authority (DRA) is the agency that develops and implements most of the legislation and regulations on pharmaceuticals. • Its main task is to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. • This is done by making certain rules that the … WebThe standards have enabled national drug regulatory authorities (NMRAs) in the EAC region, to authorise 5 medical products. In addition, harmonisation of guidelines and standards for inspection of pharmaceutical manufacturing sites has resulted in inspection of 9 manufacturing sites in the East African Community region as well as Egypt and India … WebRegulatory Framework The Petroleum Authority of Brunei Darussalam Act, Chapter 231 provides the establishment of Petroleum Authority (PA), a statutory body, acting as a … fishbeck rentals port o\u0027connor tx