Posted by FDA: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health
FDA: Drug Abuse and Dependence Section of Labelling for Human Prescription Drug and Biological Products
Instructions for Use — Patient Labelling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)
Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
TGA: GMP clearance guidance
CDSCO proposes new rule for drug product quality
Medsafe: Proposed warning statements for substances in medicines that may cause undesirable reactions
AEMPS begins the process to be designated as a notified body according to the MDR
EMA: Call for all sponsors to publish clinical trial results in EU database
EMA: Compilation of QRD decisions on stylistic matters in product information Issues Connected problems QRD Suggestions
EC: Withdrawal of the United Kingdom and EU rule in the field of Good Laboratory Practice (GLP)
Application of the European regulation on medical devices: ANSM sets up a pilot phase for the clinical investigations part
China Stops Accepting old Word Files After Formatting Problems Delay Reviews (article in Chinese)
China’s CDE has decided not to accept applications filed in the older .doc format. This action is after serious scrutiny of issues related to the formatting of the .doc file and the significant effort wasted. CDE stated that they continue to receive documents in older file format though Microsoft released new version .docx, in 2007 and this has created lots of problems for CDE officials with respect to formatting and hence as a permanent solution to this recurrent issue, CDE will not files/applications in .doc format.
FDA: Risk Evaluation and Mitigation Strategies: Modifications and Revisions
FDA: Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process
FDA: Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials-Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug
WHO five-year plan- DELIVERING QUALITY-ASSURED MEDICAL PRODUCTS FOR ALL
FDA: Using the Inactive Ingredient Database
EC: Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
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MHRA: Implementing the Falsified Medicines Directive: Safety Features
French National Agency for Medicines and Health Products Safety (ANSM)
(article in French) has issued guidance to the manufacturers of paracetamol to add an overdose warning to their product labels as “OVERDOSE = DANGER” after 85% of the 2,300 people it polled expressed a preference for warnings that began with that statement. ANSM has given the manufacturers a period of nine months to implement the labeling change.
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
FDA: Population Pharmacokinetics Guidance for Industry
FDA: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
FDA: E19 Optimisation of safety data collection
EC: Safety features for medicinal products for human use Questions and Answers – Version 15
FDA: Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry
EU: The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019
Draft legislation: supplementary protection certificate manufacturing waiver in a ‘no deal’ outcome.
Swissmedic: Information on GCP inspections
Swissmedic: Medicinal products with orphan drug status
The HPRA will now include CESP submission numbers on human medicine validation emails
FDA: Software Precertification Program 2019 Mid-Year Update
EMA takes note of the European Ombudsman’s decision on pre-submission activities
TGA: Medical device cyber security guidance for industry
FDA: Post marketing Safety Reporting for Combination Products Guidance – Final Guidance
TGA: Guidance on testing of biological medicines
CDSCO: Update on manufacturing licence renewal
ANSM launches public consultation on draft recommendations for the cybersecurity of medical devices