The Regulatory Times

December 2018

Your monthly round-up of international Life Sciences regulatory news from the past month

US

FDA – Biopharmaceutics Classification System-based biowaivers

This guidance provides recommendation to applicants on biopharmaceutics classification of drug substances and the biopharmaceutics classification system (BCS)-based biowaiver of bioequivalence studies for drug products.

This guidance only applies to immediate release, solid oral dosage forms or suspensions (pharmaceutically equivalent to the reference product) designed to deliver drug to the systemic circulation. It also applies to fixed-dose combination (FDC) products which meets dose proportional criteria. The objective of BCS-based biowaiver approach is to reduce the need for in vivo bioequivalence studies.

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EU

CMDh – Recommendations on submission dates for Applicants of the Mutual Recognition Procedure (MRP)

In this document CMDh has provided insight to facilitate planning of submission dates of new applications for Mutual Recognition.

According to this document, national holidays have not been taken into account when calculating the latest submission dates given in the Annex; applicants are advised to consider this issue to allow 14 calendar days for validation for all Concerned Member States (CMS).

The CMDh would strongly advise applicants to discuss a timetable for the procedure with the Reference Member State (RMS) before the dossier is submitted to the CMS(s) and the RMS For Details, please refer below link:

Follow the link for full details:

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CMDh – Recommendations on submission dates for Applicants of the Decentralised Procedure (DCP)

This document produced by the Coordination Group (CMDh) guide applicants to facilitate planning of submission dates of new applications going through the decentralised procedure.

National holidays have not been taken into account when calculating the latest submission dates given in the Annexes; applicants therefore have to consider this issue to allow 14 calendar days for validation for all Concerned Member States (CMS).

The CMDh would strongly advise applicants to discuss a timetable for the procedure with the Reference Member State (RMS) before the dossier is submitted to the CMS(s) and the RMS.

Follow the link for full details:

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EDQM – Revised guideline on requirements for revision/renewal of CEPs

As per the guideline, the holder of a certificate of suitability (CEP) shall inform the EDQM of any change to information in the CEP application by sending an appropriate request for revision demonstrating that the conditions laid down in the present guideline are met. In addition, this guideline describes the requirements for the renewal of CEPs and for a transfer of holdership.

Classification of changes depends upon the potential impact of the change on the quality of final Substance.

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CMDh – Publication of Decisions to Grant or Revoke a Marketing Authorisation

In accordance with Article 125 of Directive 2001/83/EC, decisions to grant or revoke a marketing authorisation shall be made publicly available.

For each Member State, the name and address of the Official Journal and/or the link to the webpage where these decisions would be published is provided in this document.

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Emerging Markets

Australia

TGA – Guidelines for Advertisements for Medicines Containing Schedule 3 Substances v1.1, Oct 2018

This guidance helps to understand majorly following two points :

  • How the TGA decision maker (the Delegate of the Secretary of the Department of Health) may determine that a Schedule 3 substance is not suitable for advertising
  • Additional information for parties advertising medicines containing Schedule 3 substances.

Follow the link for full details:

TGA Website

TGA – Provisional Registration Process. For Prescription Medicines with Provisional Determination v1.2, Oct 2018

This guidance is for those sponsors who are intrested to use provisional approval pathway for prescription medicines. The provisional registration process will allow certain medicines to be provisionally registered in the ARTG for a limited duration.

These medicines are registered on the basis of preliminary clinical data, however comprehensive non-clinical data on safety,quality and compliance with Good Manufacturing Practice is still required.

Follow the link for full details:

TGA website

TGA – Reclassification of surgical mesh devices v1.0, Nov 2018

Guidance assists sponsors of surgical mesh medical devices. Surgical mesh medical devices are a variety of surgical implants usually used in the repair of soft tissue, or mixed soft tissue/bony structural defects, to support organs and tissues or to strengthen the integrity of a body cavity.

Surgical meshes are generally designed to be integrated into the structures they support. The Australian government has approved the regulatory amendments that strengthens the review of surgical mesh medical devices those have been reclassified from Class IIB (medium) to class III (high risk).

Follow the link for full details:

TGA Website

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2018-12-17T11:40:40+00:00