Regulatory Update – July 2019

Posted by

FDA: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health

Read more…

FDA: Drug Abuse and Dependence Section of Labelling for Human Prescription Drug and Biological Products

Read more…

Instructions for Use — Patient Labelling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products

Read more…

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)

Read more…

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

Read more…

TGA: GMP clearance guidance

Read more…

CDSCO proposes new rule for drug product quality

Read more…

Medsafe: Proposed warning statements for substances in medicines that may cause undesirable reactions

Read more…

AEMPS begins the process to be designated as a notified body according to the MDR

Read more…

EMA: Call for all sponsors to publish clinical trial results in EU database

Read more… 

EMA: Compilation of QRD decisions on stylistic matters in product information Issues Connected problems QRD Suggestions

Read more…

EC:  Withdrawal of the United Kingdom and EU rule in the field of Good Laboratory Practice (GLP)

Read more…

Application of the European regulation on medical devices: ANSM sets up a pilot phase for the clinical investigations part 

Read more… 

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

Read more…

FDA: Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process

Read more… 

FDA: Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials-Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug

Read more… 

WHO five-year plan- DELIVERING QUALITY-ASSURED MEDICAL PRODUCTS FOR ALL

Read more…

FDA: Using the Inactive Ingredient Database

Read more… 

EC: Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
Read more…

MHRA: Implementing the Falsified Medicines Directive: Safety Features

Read more…

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

Read more…

FDA: Population Pharmacokinetics Guidance for Industry

Read more… 

FDA: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

Read more…

FDA: E19 Optimisation of safety data collection

Read more… 

EC: Safety features for medicinal products for human use Questions and Answers – Version 15

Read more…

FDA:  Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry

Read more…

EU:  The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019

Read more…

Draft legislation: supplementary protection certificate manufacturing waiver in a ‘no deal’ outcome.

Read more…

Swissmedic: Information on GCP inspections

Read more…

Swissmedic: Medicinal products with orphan drug status

Read more…

The HPRA will now include CESP submission numbers on human medicine validation emails

Read more…

FDA:  Software Precertification Program 2019 Mid-Year Update

Read more… 

EMA takes note of the European Ombudsman’s decision on pre-submission activities

Read more…

TGA: Medical device cyber security guidance for industry

Read more…

FDA: Post marketing Safety Reporting for Combination Products Guidance – Final Guidance

Read more… 

TGA: Guidance on testing of biological medicines

Read more…

CDSCO: Update on manufacturing licence renewal

Read more…

ANSM launches public consultation on draft recommendations for the cybersecurity of medical devices 

Read more…

WHO: Quality Management System 3 Requirements for national inspectorates (draft for comments)

Read more…

UK:  NICE announces details of health technology evaluation methods review

Read more…

EC: Single-use medical devices-safety and performance requirements for reprocessing

Read more…

FDA: Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions

Read more…

TGA: Use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs)

Read more…