Regulatory Update – December 2019

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EC: Clinical trial regulations (EU) NO 536/2014 (draft guidance)

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FDA: Adaptive designs for clinical trials of drugs and biologics

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Draft PIC/S Recommendation on how to evaluate /demonstrate the effectiveness of a pharmaceutical quality system in relation to risk-based change management

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Corrigendum to MDR

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Corrigendum to IVDR

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MEDSAFE: Guideline on marketing products which are not approved medicines

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CDSCO: Measures to strengthen adverse event reporting of medical devices

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TGA: Update on safety and performance concerns of suspended breast implants

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FDA: Draft guidance for evaluating novel excipients

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FDA: Interstitial cystitis/bladder pain syndrome (IC/BPS): Establishing the effectiveness of drugs for treatment (draft guidance)

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EC: Technical guidance on UDIs

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FDA: Updates and press announcements on NDMA in Zantac (ranitidine)

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HPRA: Reduction in fee increase post comments from industry

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FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

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FDA: Magnetic Resonance (MR) Coil – performance criteria for safety and performance-based pathway (draft guidance)

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EMA update on metformin diabetes medicines

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Health Canada evaluating NDMA in metformin drugs

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MEDSAFE recommends reclassifying products containing Codeine as prescription drugs

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TGA: Comparable overseas bodies (COBs) for complementary medicines

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US Senate passes OTC drug monograph reform bill

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EMA: Improvement in signal management after implementation of pharmacovigilance reforms

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EC: MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

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EC: MDCG 2019-14 Explanatory note on MDR codes

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EMA: Guideline on good pharmacovigilance practices (GVP) – Product- or Population-specific considerations III: Pregnant and breastfeeding women

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FDA: Guidance for paediatric studies of molecularly targeted oncology drugs: Amendments to Sec. 505B of the FD&C Act (draft guidance)

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Finland: Revised regulation on clinical trials

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EMA: Guide on access to unpublished documents – Documents access and publication (DAP) service

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FDA: Medical Device Submissions: Amending premarket regulations that require multiple copies and specify paper copies to be required in electronic format

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FDA: Qualification process for drug development tools (draft guidance)

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FDA: Revised procedures for the announcement of approvals and denials of premarket approval applications and humanitarian device exemption applications

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ISO 14971:2019: Medical devices — Application of risk management to medical devices

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EMA: Launch of an international pilot programme on inspection of manufacturers of sterile medicines

https://www.ema.europa.eu/en/news/launch-international-pilot-programme-inspection-manufacturers-sterile-medicines

FDA: Guideline on the importation of prescription drugs from Canada

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EC: MDCG 2019-15 Guidance notes for manufacturers of Class I medical devices

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FDA: Bridging for drug-device and biologic-device combination products

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WHO prequalifies first biosimilar medicine to increase worldwide access to life-saving breast cancer treatment

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