Regulatory Updates – March 2020

Posted by

FDA: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

Read More… 

FDA: Product-Specific guidance for generic drug development

Read More…

TGA: Medicine shortages: Report on the first 12 months of the mandatory reporting scheme

Read More…

FDA: Bone Anchors – Premarket Notification (510(k)) Submissions

Read More…

Philippines FDA: Guidelines for pharmaceutical industry on pharmacovigilance

Read More…

CDSCO: Submission and processing of application for registration certificate and import license in parallel with new drug application

Read More…

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

Read More…

Philippines FDA: FDA to start receiving application based on ASEAN harmonized technical requirements

Read More…

EC: Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

Read More…

FDA: FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast

Read More… 

The Future Relationship with the EU – The UK’s Approach to Negotiations

Read More…

EMA: EMA organisational changes come into effect

Read More…

FDA: Notice to Compounders: Changes that affect compounding as of March 23, 2020

Read More…

FDA: Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment

Read More…

FDA: Inclusion of Older Adults in Cancer Clinical Trials (draft guidance)

Read More…

FDA: Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control (draft guidance)

Read More… 

FDA: Providing Regulatory Submissions in Alternate Electronic Format (draft guidance)

Read More…

TGA: Update on reclassification of number of medical devices

Read More… 

FDA: 510(k) Third Party Review Program

Read More…

Denmark: New enhanced reporting requirement is to strengthen the surveillance of medical devices

Read More…

FDA: Guidance on Competitive Generic Therapies

Read More…

EC: Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)

Read More…

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR regarding devices covered by certificates according to MDD or AIMDD

Read More…

MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

Read More…

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

Read More…

MDCG 2019-8 v2 – 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…

MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI

Read More…

CDSCO: Testing of all categories of new drugs for their approval

Read More…

Requirement of CMC documents for approval of additional indication of an already approved drug product

Read More…

Requirement of process validation report for permission to conduct Clinical trial/BA-BE studies

Read More…

Guideline for approval of synthetically manufactured drug which has II been previously approved as r-DNA derived drug

Read More…

Malaysia: DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT FOR PUBLIC COMMENT

Read More…

FDA: Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products (draft guidance)

Read More…

HPRA: Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy

Read More…

EC: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

Read More…

FDA: Post marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

Read More…

EC: 12th designated notified body under MDR

Read More…

FDA: Policy for Certain REMS Requirements During the COVID19 Public Health Emergency

Read More…

MedTech Europe calls for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard Healthcare Systems

Read More…

Swissmedic: Placing essential ventilators on the market

Read More…

EC: Coronavirus: harmonised standards for medical devices to respond to urgent needs

Read More…

FDA: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act

Read More… 

FDA: Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency

Read More…

TGA: Consultation on Scope of Regulated Software based products

Read More…

TGA: Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines

Read More…

MHRA: List of medicines that cannot be parallel exported from the UK

Read More…

FDA: Coronavirus Treatment Acceleration Program (CTAP)

Read More…