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  • Regulatory NewsRegulatory News

    European Commission Explores the Future of HTA Cooperation

    The European Commission on Friday opened a consultation to consider the views of a number of different stakeholders on the future of health technology assessments (HTAs) across the EU member states. The commission is looking to track the experiences in the current system and the on-going cooperation mechanisms, as well as any future needs and opinions on the proposed approach in the Inception Impact Assessment . Specifically, the EC is looking to hear more on a number...
  • Feature ArticlesFeature Articles

    Drug Development in Asia: Scattering the Mist

    This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape. Introduction Asia is a huge landmass with contrasting physical and human geographies. The economic panorama within this rich milieu of human geography has become one of Asia's most prominent features, and many major pharmaceutical companies are acquainting themselves with the unique regulatory and medical landscape ...
  • Regulatory NewsRegulatory News

    FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation

    US and Canadian healthcare product regulators are continuing to move forward in a joint effort to harmonize the way in which both countries regulate pharmaceuticals, medical devices, biological products and veterinary drugs. Background The effort, known as the US-Canada Regulatory Cooperation Council (RCC), was started in 2011 in the hopes of increasing regulatory cooperation and eliminating economic barriers to doing business between (and in) the two countries. The ...
  • Taiwan's FDA Says it is Aiming for 2013 Induction into PICS

    Taiwan is preparing to join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) in 2013, vaulting ahead of several other Asian countries preparing to do the same, reports Taiwan Today . PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and chiefly works to promote the quality of pharmaceutical products. The organization is made up of two distinct parts which are different in regard to the...
  • Taiwan's FDA Says it is Aiming for 2013 Induction into PIC/S

    Taiwan is preparing to join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) in 2013, vaulting ahead of several other Asian countries preparing to do the same, reports Taiwan Today . PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and chiefly works to promote the quality of pharmaceutical products. The organization is made up of two distinct parts which are different in regard to the...
  • EMA to Engage in Cooperative Activities with European Drug Monitoring Agency

    The European Medicines Agency (EMA) is announcing an enhanced cooperation scheme with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) which will see an improved exchange of information on psychoactive medicines or other medicines likely to be abused by some patients and consumers. The program is a part of the recently implemented EU pharmacovigilance legislation , a portion of which called for EMA and EMCDDA to, "Exchange information that they recei...
  • Feature ArticlesFeature Articles

    It’s a Small World: Collaboration and Harmonization in an Ever-shrinking World

    The increasing globalization of the pharmaceutical world means the old saying, "It's a small world," is truer now than ever before. However, although the pharmaceutical industry is now truly global, diversity in regulations and standards remains a difficult challenge for the regulatory authorities and industry. The increased globalization of the pharmaceutical sector has meant more research and development (R&D) and manufacturing facilities are being established in ...
  • China: Milestone Meeting Held Between Chinese, Taiwanese Regulators

    The first "cross-strait" Pharmaceuticals Inspection Technology seminar was jointly organized by the Chinese Food and Drug Testing and Research Institute, the Taiwanese Food and Drug Administration, and the Fujian Institute for Drug Control and held in Fuzhou, Fujian, on 6-7 June 2012. The seminar served to actively implement the bilateral "cross-strait medical and health cooperation agreement" signed by the Fujian Provincial People's Government and the State Food and ...
  • World: Regulatory Agencies Attend WHO Seminar

    Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate. The meeting, an international seminar hosted by the World Health Organization (WHO), included representatives from Australia, Argentina, Brazil, France, India, Portugal, South Africa, the United States and the UK. A total of 30 regulatory agencies attended the meeting. The meeting coincided with the WHO'...
  • US, British Pharmacopoeias Tout Effort to Harmonize Drug Standards

    • 15 May 2012
    The US Pharmacopoeia (USP) and the British Pharmacopoeia (BP) have announced the harmonization of two drug product quality standards for two eye drop medications-a first for the two groups and an effort that could lead to more cooperation between the two groups in the future. The newly-harmonized standards cover dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution, and are included in the Pharmacopeial Forum 38(...
  • US: IoM Report Calls FDA Inspections Impractical

    In its report,  Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad , the Institute of Medicine (IOM) underscores that the US Food and Drug Administration's (FDA) traditional method of ensuring product safety-periodic inspections is impractical. FDA currently inspects 20 million types of products manufactured at 300,000 factories in 150 different countries and imported through 300 ports of entry. IOM's report states FDA "needs mana...
  • Topic of Regulation Central to APEC Meeting

    Regulators from Asia-Pacific Economic Cooperation (APEC) member countries discussed the topic of regulation and its effect on member economies during a recent meeting in Russia, according to press releases from the meeting. The trade liberalization forum of 21 nations met in Moscow in February to discuss ways to increase market access to the Asia-Pacific region by 25% in the next four years. The organization particularly focuses on the movement of physical goods, which i...