The Regulatory Times

September 2018

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

US

Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

This guidance provides insight to manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), for orally administered immediate-release (IR) drug products that contain highly soluble drug substances.

This guidance helps in deciding the dissolution testing and specification criteria for Immediate-Release Solid Oral Dosage Forms containing Biopharmaceutics Classification System Class 1 and 3 Drugs as it is based on the solubility of the drug substance in the drug product. Thus, it is not necessary to refer biopharmaceutics classification system (BCS) class 1 and class 3 because permeability requirements are not within the scope of this guidance.

The recommendations in this guidance provide insight to industries on Dissolution Testing of Immediate Release Solid Oral Dosage Forms (August 1997) for high solubility drug substances in IR drug products .
For drug substances that are not been covered in this guidance, need to follow the recommendations provided in the August 1997 guidance.

For details please refer to the link provided below:

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Elemental Impurities in Drug Products

This guidance suggests the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities (ICH Q3D).

With implementation of ICH Q3D and of USP General Chapters <232> and <233>, this guidance assist on the following aspects:

  • How applicants submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for noncompendial drug products should control elemental impurities as described in ICH Q3D.

  • How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP General Chapters <232> and <233> .

  • How holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with General Chapters <232> and <233> and 21 CFR 314.70.

  • How manufacturers of noncompendial drug products that are marketed without an approved NDA or ANDA should control elemental impurities.

Follow the link for full details:

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EU

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

EMA has updated its post-authorization procedural advice for users of the centralized procedure to clarify that companies should notify agency in six months advance when they plan to file a type II variations involving additions of new therapeutic indication(s) or modification of already approved one(s) under scope C.I.6.

Follow the link for full details:

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CMDh Best Practice Guide on the use of the Electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralised Procedures (CMDh/084/2008/Rev.6)

This guidance has been developed to support the use of the eCTD as a submission format in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) and explains how an applicant can meet their legal obligations within MRP and DCP using eCTD format.

National requirements to provide partial paper copies in addtion to eCTD must be complied by applicants.

Follow the link for full details:

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CMDh procedural advice on changing the Reference Member State

The CMDh has included a clarification in the CMDh procedural advice on changing the RMS according to which, MAHs can approach the CMDh for support in case all CMSs have refused to become RMS. Some of the clarifications included in the guidelines are as follows :

  • Applicants are strongly advised to address their switch request to just one proposed new RMS.

  • In case there is no CMS with all strengths approved, there are two options for the MAH: 1) To apply for a RUP in the current RMS to include the proposed new RMS as CMS before the switch; 2) In those cases it would be allowed to address two proposed new RMS and to split the procedure.

  • Smallest possible number of new RMS should be chosen.

  • It is highly recommended to use the worksharing procedure for upcoming variations in order to keep harmonization.

Follow the link for full details:

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Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

Following the publication of a practical guidance related to medicinal products authorised via the centralised procedure by the EMA in June, the CMDh has updated its practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP.

Follow the link for full details:

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Emerging Markets

Australia

Australian regulatory guidelines for biologicals (ARGB) – July 2018

This guidance:

  • Provides information on supplying and using human cell and tissue-based therapeutic goods, and live animal cells, tissue and organs.

  • Explains the legislative requirements outlined in the regulatory framework for biologicals, including specific biological standards.

The Australian Regulatory Guidelines for Biologicals has been restructured and updated in line with new legislative changes with this updation.

Follow the link for full details:

TGA Website

Varying biological entries on the ARTG – Version 1.3 July 2018

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biologicals regulated under the Biologicals Regulatory Framework that are included in the ARTG under Part 3-2A of the Therapeutic Goods Act 1989.

Following updates are done with this version:

  • Clarification provided for Multiple ARTG entries (Relevant to submission of application step).

  • Link to new Biologicals application form guidance (Relevant to submission of application step).

Follow the link for full details:

TGA Website

General Dossier Requirement – Version 1.4 July 2018

This guidance assists the applicants, to meet Agency requirements for the dossier of information to be sent to agency for evaluation in support of the following types of applications:

  • To register a medicine (prescription, OTC or complementary) on the ARTG.

  • To include a biological on the ARTG that requires evaluation of information.

  • To include a medical device (including IVD) on the ARTG if you have been advised that it will be audited & requested to provide information for the audit.

  • To list an assessed listed medicine (where information is required for evaluation).

  • For medical device (including IVD) conformity assessment certification.

  • For evaluation of new ingredients for use in listed medicines.

The following updates are done with this version:

Amendments in formatting of the dossier for biological.

Follow the link for full details:

TGA Website

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2018-09-05T08:54:40+00:00