RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • RoundupsRoundups

    Euro Roundup: EMA shares draft guidance on protecting confidential data in CTIS

    The European Medicines Agency (EMA) has published draft guidance on protecting personal data and commercially confidential information uploaded to the Clinical Trial Information System (CTIS).   CTIS allows the submission and storage of clinical trial information to support the Clinical Trials Regulation (CTR). Through CTR, the EU has made a single-entry point for submitting data and documents related to clinical trials and created a source of publicly available inform...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA cites two on pharmacovigilance compliance

    Australia’s Therapeutic Goods Administration (TGA) has issued infringement notices to two drugmakers over alleged breaches of the rules on pharmacovigilance. The two fines, each of which is for AU$13,320 ($9,890), relate to the alleged failure to provide information on a contact person responsible for medicine safety.   TGA frequently issues infringement notices, but they typically relate to breaches of advertising rules or importation of medicines. TGA hit Arthropha...
  • RoundupsRoundups

    Euro Roundup: MDCG adds guidance on legacy devices, Eudamed to IVDR to-do list

    The Medical Device Coordination Group (MDCG) has updated its joint implementation and preparedness plan for the In Vitro Diagnostic Regulation (IVDR), adding sections on legacy devices and Eudamed in recognition of the need for guidance on what will happen in May 2022.   With the EU staggering the implementation of IVDR, more tests will become legacy devices – products  that are placed on the market under the old directive – than  was originally planned. IVDR makes a r...
  • RoundupsRoundups

    Asia-Pacific Roundup: Australia to clear barriers to drug imports

    Australia’s Therapeutic Goods Administration (TGA) is planning legal changes to support the importation of overseas substitutes for pharmaceutical products that are no longer on the local market. TGA set out the plan after receiving general support in a consultation last year.   The survey sought feedback on four potential ways to manage or mitigate drug shortages. One option would grant annual charge waivers to enable the import of overseas substitutes for discontinue...
  • RoundupsRoundups

    Euro Roundup: MedTech Europe updates ethical code

    MedTech Europe has updated its Code of Ethical Business Practice considering the evolution in standards since it last revised the document in 2015. The updated text features additional information on topics including collaborative research and third-party intermediaries, plus a new annex about calculating the value of in-kind educational grants.   The trade group revised the Q&A associated with the 2015 code last year but otherwise left the content unchanged. Recognizi...
  • RoundupsRoundups

    Asia-Pacific Roundup: Philippine FDA seeks feedback on expedited evaluation of medical devices

    The Philippine Food and Drug Administration (FDA) is seeking feedback on the expedited review of medical devices that already have been authorized by another national regulatory authority (NRA) in the Association of Southeast Asian Nations (ASEAN).   In line with World Health Organization advice about the benefits of relying on other regulatory agencies, FDA has set out draft guidelines on the abridged processing of fillings for registration and notification of certain...
  • RoundupsRoundups

    Euro Roundup: EFPIA urges a rethink of COVID vaccine IP waiver

    EFPIA has called on European governments to readdress a proposal to waive Trade Related Intellectual Property Rights (TRIPS) for COVID-19 vaccines and instead focus on what it perceives to be “the real barriers to global vaccine equity,” in reaction to a compromise reached through talks involving the European Union.   Negotiations between the EU, South Africa, India and the US have resulted in a compromise that the World Trade Organization (WTO) director general Ngoz...
  • RoundupsRoundups

    Asia-Pacific Roundup: India consults on voluntary medical device marketing code

    The Indian Department of Pharmaceuticals (DoP) is seeking feedback on a proposed Uniform Code for Medical Devices Marketing Practices (UCMDMP). DoP drafted the code in response to a request from the medical device industry, which currently must comply with the rules on pharmaceuticals but wants its own voluntary regulatory requirements.   UCMDMP shares a structure and some similarities with the Uniform Code for Pharmaceuticals Marketing Practices, published late in 2...
  • RoundupsRoundups

    Euro Roundup: PRAC recommends new safety information for two COVID vax

    The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the safety information on COVID-19 vaccines from Johnson & Johnson and Moderna.   PRAC wants to add small vessel vasculitis with cutaneous manifestations as a side effect of J&J’s vaccine. The side effect describes inflammation of blood vessels in the skin which may result in rash and bruising. Infections, medicines and vaccines can cause small vessel vascu...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA consults on repurposing medicines – again

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on the repurposing of medicines for the second time in 12 months. The latest initiative builds on the first consultation by seeking views on topics including intellectual property and how to incentivize organizations to repurpose medicines.   TGA draws a distinction between the label extensions that sponsors apply for when a medicine still has patent protection and identifying novel clinical uses of...
  • RoundupsRoundups

    Euro Roundup: EC cleared to negotiate international pandemic treaty

    The European Council has authorized the European Commission to negotiate an international agreement on the prevention, preparedness and response to pandemics. By 2024, European authorities hope to have in place an instrument that equips the world to accelerate detection of and response to pandemics.   European officials publicly floated the idea of an international treaty on pandemics late in 2020 and the Council adopted a decision to support the launch of negotiations...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback on planned changes to listed medicine guidelines

    Australia’s Therapeutic Goods Administration (TGA) has proposed a near-total overhaul of its guidelines on how to demonstrate the efficacy of listed medicines and released its draft for consultation.   In Australia, the term “listed medicine” covers unscheduled products with well-known, low-risk ingredients, usually with a long history of use. The category allows companies to bring products such as vitamins and minerals to market without undergoing premarket assessment...