The Regulatory Times

April 2019

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


Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This guidance explains the FDA’s policy for evaluating bulk drug substances nominated for use in compounding by outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503B of the FD&C Act directs the FDA to develop a list of bulk drug substances for which there is a clinical need (the 503B Bulks List). Drug products compounded using bulk drug substances on the 503B Bulks list qualify for certain exemptions from the FD&C Act, provided the other conditions in section 503B are met. This guidance addresses FDA policies for developing the 503B Bulks List, including the Agency’s interpretation of the phrase ‘bulk drug substances for which there is a clinical need’, as it is used in section 503B. This guidance also addresses the factors and processes by which the Agency intends to evaluate and list bulk drug substances.

Drug products compounded under the conditions in section 503B are not exempt from current good manufacturing practice (CGMP) requirements in section 501(a)(2)(B) of the FD&C Act.

Bulk drug substances used in compounding under section 503B must also meet certain other statutory requirements, including the following:

  1. If an applicable monograph exists under the United States Pharmacopeia (USP), National Formulary (NF), or another compendium or pharmacopeia recognized by the Secretary under section 503B, the bulk drug substance must comply with the monograph;
  2. The bulk drug substance must be manufactured by an analysis.

A more detailed discussion of the analysis is included in this guidance to evaluate bulk drug substances that have been nominated for inclusion on the 503B Bulks list.

For details please refer to the link provided below:

FDA Website


The MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

The MHRA has published additional guidance covering the process for applying for a Certificate of Pharmaceutical Product (CPP) in case the UK leaves the EU without a deal.

If this happens, the MHRA will become the UK’s stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

The MHRA will continue to offer existing services for issuing a Certificate of Pharmaceutical Product (CPP). The normal service takes 10 days and a 2-day service is available for urgent requests.

If the UK leaves the EU without a deal, the MHRA will be able to issue a CPP for a grandfathered centrally authorised product (CAP). A grandfathered CAP is a CAP marketing authorization automatically converted to a UK marketing authorization.

Follow the Gov.UK links below for full details:

MHRA Guidance and Publications on a Possible No-Deal Scenario

Applying for a Certificate of Pharmaceutical Product in a No-Deal Scenario

Mandate of the Joint CMDh/CMDv Working Party on Variation Regulation

The mandate of the Working Party on Variation Regulation was established to provide recommendations to the CMDh and CMDv on below matters:

  • To prepare proposals for updated CMD guidance and documents to the revised Variation Regulation
  • To give inputs to EC proposals, e.g. for future update of guidelines and application forms
  • To reach a common interpretation of the revised Variation Regulation in order to ensure a consistent approach with regards to variation procedures
  • To discuss common topics with the EMA such as recommendations on the classification of unforeseen variations and work sharing.
  • To promote the use of the work-sharing procedure.

Follow the link for full details:

HMA Website

Emerging Markets


New Drugs and Clinical Trials Rules 2019

These rules lay out regulations for new drugs as well as the approval and conduct of clinical trials in India. Relevant forms are annexed for submissions made under these rules.

Follow the link below for full details:

CDSCO Website


Guidance for TGO 101: Standard for Tablets, Capsules and Pills v1.0, April 2019

This guidance is to help sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring that these types of therapeutic goods are of appropriate quality.

The information in this guidance may also assist other stakeholders to understand how sponsors and manufacturers assure that medicines that are tablets, capsules or pills are of good quality.

Compliance with TGO 101 is not necessarily sufficient to demonstrate quality, safety or efficacy for the purposes of registering or listing a medicine. Additional requirements may be applied, for example, as conditions of listing or conditions of registration.

In some instances, compliance with TGO 101 may not be sufficient to establish the safe use of medicines. Sponsors will need to further consider the intended patient population, size of the recommended daily dose, etc. to ensure that their medicines are safe for the purpose for which they are to be used.

Consideration must also be given to any other relevant standards.

Follow the link below for full details:

TGA Website

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