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  • Feature ArticlesFeature Articles

    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...
  • Regulatory NewsRegulatory News

    German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies

    Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories. The non-compliance report calls out the site, which manufactures and packages non-sterile capsules and tablets, for one critical deficiency related to the essential elements of its...
  • Regulatory NewsRegulatory News

    EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

    The European Medicines Agency (EMA) on Thursday released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across international regulatory efforts. EMA says the report was developed on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA) to "provide a general overview of multi-project initiatives in which multiple regulators were involved." Backgro...
  • Regulatory NewsRegulatory News

    WHO Seeks API Manufacturers for Prequalification Program

    The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
  • Feature ArticlesFeature Articles

    Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

    This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting. Developing a Global Strategy for Early Consultations Are you developing an innovative medical device? Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/...
  • Feature ArticlesFeature Articles

    China's Regulatory Procedure and Inspection System

    China is a mysterious and interesting country for the regulatory professional. It is of interest because of its enormous market potential (nearly a fifth of the world’s population lives in the People’s Republic of China) and the fact that China is one of the most important manufacturers of active pharmaceutical ingredients (APIs) for the EU and US. China exported 1.2 million tons of APIs to the EU and 0.6 million tons to the US in 2013. China is somewhat mysterious becau...
  • India's CDSCO Orders Local Authorities to Adhere to Drug Regulations

    India's Central Drugs Standard Control Organization (CDSCO) issued directions to local authorities on 12 October 2012 to comply with the requirements of the national Drugs and Cosmetics Act concerning the grant of licenses for new and generic drugs.  For generic drugs, local authorities were told that licenses can only be granted for generics under the generic name of the formulation, In the case of formulations containing multiple ingredients, the license should...
  • EMA Releases Updated Final Guideline on Active Substance Master Files

    A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...