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    Euro Roundup: EMA starts first real-world evidence studies under DARWIN EU

    The European Medicines Agency (EMA) has begun the first real-world evidence (RWE) studies under its DARWIN EU initiative, kicking off three projects at the start of the “rapid ramp-up” of a program intended to support regulatory decision making.   DARWIN (Data Analysis and Real World Interrogation Network) EU is designed to give EMA, the European Commission and national competent authorities in the 27 member states access to the results of analyses of real-world health...
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    Asia-Pacific Roundup: Singapore’s HSA finalizes LDT guidelines

    Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.   To date, HSA has not directly overseen laboratory-developed tests (LDTs) – those tests developed in-house by Ministry of Health licensed laboratories for clinical diagnostic use solely within their own facilities. HSA now thinks it needs to regulate LDTs to ensure they meet essential manufa...
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    Asia-Pacific Roundup: Malaysia’s MDA updates guidance on labeling, change notifications for devices

    Malaysia’s Medical Device Authority (MDA) has updated its guidance on the requirement for labeling of medical devices and the handling of change notifications of authorized products.   MDA published the fifth edition of the labeling guidance in June, but has since identified a few things to change, resulting in a sixth edition released this week that hews closely to its predecessor. MDA has deleted two definitions “generic name” and “specific name” from the glossary an...
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    Euro Roundup: EMA consults on planned update to computerized systems annex of GMP guide

    The European Medicines Agency (EMA) is seeking feedback on the planned revision of the good manufacturing practice (GMP) annex on computerized systems. The agency wants to revise the existing text, which dates to 2011, because it “does not give sufficient guidance within a number of areas.”   Annex 11 applies to all sets of software and hardware components, which EMA defines as computerized systems that are used as part of GMP-regulated activities. The annex is used in...
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    Asia-Pacific Roundup: Indonesia revokes licenses of suppliers linked to contaminated cough medicines

    The Indonesian Food and Drug Authority (BPOM) has revoked the licenses of two ingredient suppliers as part of its investigation into contaminated cough syrups linked to the deaths of 195 children.   Responding to the deaths and cases of acute kidney injury, BPOM has carried out inspections and tried to trace the sources of raw materials that contain levels of ethylene glycol and diethylene glycol above the acceptable threshold. The work led the regulatory agency to r...
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    Euro Roundup: EFPIA proposal seek to reverse EU’s shrinking share of R&D pie

    Regulatory flexibility and agility, plus a supportive clinical trial environment, are keys to increasing the R&D investment in the EU, according to EFPIA (European Federation of Pharmaceutical Industries and Associations).   After seeing Europe’s share of global biopharma research and development investment fall from 41% to 31% over the past 20 years, EFPIA issued recommendations to address areas of concern. The list includes a comment on the increasing importance of m...
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    Asia-Pacific Roundup: MSF accuses UK of ‘seeking to gut India’s patent and drug regulatory laws’

    Médecins Sans Frontières (MSF) has accused the UK of trying to remove safeguards from India’s patent and drug regulatory laws that make the Asian country “a manufacturing powerhouse.” MSF made the statement after reviewing a leaked copy of a section of a draft free trade agreement (FTA).   The leaked intellectual property chapter of the proposed FTA discusses topics including patents, stating that each country should provide pharma companies with “an adequate and effec...
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    Euro Roundup: MDCG publishes guidance on MDR, IVDR authorized representative requirements

    The Medical Device Coordination Group (MDCG) has published guidance on the role and requirements of authorized representatives under the new medtech regulations. In the guidance, MDCG unpacks what the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) mean for authorized representatives, manufacturers and other economic operators.   EU regulations require manufacturers without a presence in a member state to appoint a sole authorized representat...
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    Asia-Pacific Roundup: Malaysia’s MDA posts draft guidance on custom-made medical devices

    Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft guidance about seeking permission to import or place custom-made medical devices on the market. The guidance covers the notification process for custom products that address the lack of adequate commercially available products.   In the draft, MDA explains the proposed general requirements for custom-made medical devices, which are intended for specific patients and manufactured in accordance with a...
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    Euro Roundup: UK delays new Medical Device Regulations by 12 months

    The UK has delayed the implementation of the future Medical Device Regulations as part of the government’s commitment to an approach that “supports system readiness and minimizes the risk of supply disruptions.” The target date for the new regulation is now July 2024.   The government framed the delay as part of its commitment to “ensuring that there is a proportionate approach to its implementation” that reduces the risk of disruption. The Medicines and Healthcare pro...
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    Asia-Pacific Roundup: Pakistan’s DRAP tells companies to test solvents amid oral drug contamination concerns

    The Drug Regulatory Authority of Pakistan (DRAP) has told manufacturers of oral formulations working with glycerin, propylene glycol and sorbitol to test the solvent for impurities and contaminants in response to child deaths in Gambia linked to contaminated cough syrup.   Contamination with diethylene glycol (DEG) and ethylene glycol (EG) can cause symptoms including abdominal pain and diarrhea and ultimately lead to death, particularly in children. The threat of the ...
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    Euro Roundup: Commission proposes ways to improve the security of medicine supply

    Perceived regulatory complexity is a key driver of supply chain vulnerabilities for medicinal products, according to a European Commission staff working document created to present the findings of talks between the Commission, industry and other stakeholders.   Last year, the Commission started a dialogue with “actors in the pharmaceuticals manufacturing value chain,” public authorities, patient and nongovernmental organizations, and the research community to understan...