Regulatory Updates-August 2020

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FDA: Purple Book, lists of licensed biological products with reference product exclusivity and bio similarity or interchangeability evaluations

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TGA: 3-D printing (additive manufacturing) of medical devices

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Philippines: Drafts for comments of administrative order “adoption of the collaborative procedure for the accelerated registration of world health organization (who) – prequalified drug products and vaccines”

https://ww2.fda.gov.ph/index.php/drafts-for-comments/685762-drafts-for-comments-of-administrative-order-adoption-of-the-collaborative-procedure-for-the-accelerated-registration-of-world-health-organization-who-prequalified-drug-products-and-vaccines

FDA: Pediatric study plans, content of and process for submitting initial pediatric study plans and amended initial pediatric study plans guidance for industry

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FDA: Limited population pathway for antibacterial and antifungal drugs (guidance for industry)

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EMA: Joint Audit Programme for EEA GMP inspectorates

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Swissmedic: Authorisations for non-conforming medical devices

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Swissmedic: Modification of various documents relating to authorisation

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EMA: Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

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FDA: Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format (guidance for industry)

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EC: Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)

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FDA: Drug-Drug Interaction Assessment for Therapeutic Proteins (draft guidance)

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EC: Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

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TGA: Independent review of the reforms to the therapeutic goods advertising framework complete

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CDSCO: Procedure for FDCs relating to vitamins, minerals, and micronutrients

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FDA: Registration and Listing of Medical Devices during the COVID-19 Pandemic

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FDA: Importing Medical Devices During the COVID-19 Pandemic

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UK MHRA: Guidance for industry on MHRA’s expectations for return to UK on-site inspections

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UK MHRA: MHRA response and Strategy for the Application of Analytical Quality by Design concepts to pharmacopeial standards for medicines

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FDA: Conventional Foley Catheters – Performance criteria for safety and performance based pathway

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FDA: Cutaneous Electrodes for Recording Purposes – Performance criteria for safety and performance-based pathway

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Health Canada: Order to extend review period of clinical trial applications and amendments

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FDA: Compliance policy for the quantity of bioavailability and bioequivalence samples

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Philippines FDA: Guidelines for imported pharmaceutical products from foreign trader

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MEDSAFE: Guideline on the Regulation of Therapeutic Products in New Zealand

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TGA: Evaluation of substances for use in listed and assessed listed medicines

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FDA: Manufacturing, supply chain, and drug and biological product inspections during covid-19 public health emergency questions and answers

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EDQM: Nitrosamines risk assessment: update for CEP holders

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FDA: New MAPP to describe the policies and procedures for notifying an applicant or a holder of a new drug application or a biologics license application about certain types of safety studies conducted in the Sentinel System.

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EC: Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices

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Philippines FDA: New normal operational guidelines of the Food and Drug Administration

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TGA: Clinical trial notification (CTN) form – user guide

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FDA: FDA works to mitigate shortages of rifampin and rifapentine after manufacturers find nitrosamine impurities

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Danish Medicines Agency: Relaxation: Information on face masks permitted to be in Swedish, Norwegian or English besides Danish

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Health Canada: Biopharmaceutics Classification System (BCS) based biowaiver evaluation template

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FDA: New manual of policies and procedures (MAPP) for transferring ownership of drug applications for generics

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FDA: Product-Specific Guidance for Generic Drug Development

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