Regulatory Update – October 2019

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FDA: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients (draft guidance) 

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MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 

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Review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia 

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FDA: Biological responses to metal implants in medical devices 

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URGENT/11 Cybersecurity vulnerabilities in a widely used third-party software component may introduce risks during the use of certain medical devices: FDA safety communication 

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IMDRF: Principles and practices for medical device cybersecurity (Draft guidance) 

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FDA updates and press announcements on NDMA in Zantac (ranitidine) 

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EMA advises companies on steps to take to avoid nitrosamines in human medicines 

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HPRA: EU falsified medicines legislation – Update on national arrangements for implementation 

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Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letters to industry 

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Guidance for applying for a Certificate of Pharmaceutical Product after Brexit 

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Medicines that cannot be parallel exported from the UK 

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Application of transitional provisions concerning the validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC 

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US FDA: Bioanalytical Methods Templates 

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TGA update on ranitidine shortage 

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CDSCO: List of medical devices testing laboratory  

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CDSCO: Measures to improvise regulatory guidance 

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Reinstatement of ICH Q3C(R6) Guideline available now on the ICH website 

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FDA: Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination 

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UK: Update on continuity of medical supplies 

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FDA: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling 

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Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations 

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EC’s first notified body designation under IVDR  

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HPRA: Annual Review and Proposal for Fees – Financial Year 2020 

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MHRA drug alert issued as GlaxoSmithKline recalls all unexpired stock 

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Scottish Government overview of ‘no deal’ Brexit preparations 

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EMA: Post-orphan medicinal product designation procedures Guidance for sponsors applying via the IRIS online portal 

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FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens 

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NPRA: Drug registration guidance  

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PIC/S stakeholder’s consultation on the manufacture of ATM and biological products 

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Medsafe: Medical devices adverse reporting 

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Guidelines for using TGA assessed claim on medicine labels  

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Medsafe: Appendix 8 Data Requirements for New Medicine Applications and Changed Medicine Notifications 

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CDSCO: External performance evaluation of IVD’s under MDR-further guidance 

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FDA: Answers to questions on 510(k) third-party review program 

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EC: GUIDELINES on Good Clinical Practice specific to Advanced Therapy Medicinal Products 

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FDA: Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry 

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MHRA: Updated guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal 

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EC: Designating authority’s final assessment form: Key Information  

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FDA: Using the Inactive Ingredient Database; Draft Guidance for Industry; Availability 

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FDA: Drug Master Files (draft guidance) 

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EMA: Wording of therapeutic indication, a guide for assessors of centralised applications 

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EC: MDCG 2019-6 v2 questions and answers: Requirements relating to notified bodies 

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Hong Kong proposes a regulatory framework for cell and gene therapies 

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Malaysia: Active Pharmaceutical Ingredient (API) information (Part II S) for QUEST3+ product registration application 

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FDA: Identification of manufacturing establishments in applications submitted to CBER and CDER questions and answers 

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CDSCO classifies ultrasound equipment as drugs 

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EMA: Questions & Answers on the implementation of medical devices and ivitro diagnostic medical devices regulations ((EU) 2017/745 and (EU) 2017/746) 

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MHRA: Comparator products in Bioequivalence/Therapeutic equivalence studies after Brexit 

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MHRA guidance and publications about a possible no-deal Brexit 

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FDA: Modified list of standards for premarket device reviews 

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FDA: Breast Implants – Certain Labeling Recommendations to Improve Patient Communication 

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EMA: Notification on arrangements for requesting and receiving EMA certificates through the urgent and standard procedure from November 2019 to January 2020 

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Swiss medic: Details on filing renewal applications 

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FDA: Medical Devices; exemptions from premarket notification: Class II devices; request for comments 

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FDA: Drug Products labelled as homeopathic guidance for FDA staff and industry (draft) 

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FDA: Postmarketing studies and clinical trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act  

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EC: MDR/IVDR guidance explained 

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