The Regulatory Times

March 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


Regulatory Information – Adjusted Fees for Applications to EMA from the 1st of April 2019

The EMA reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on the 1st of April 2019.

Every year, the European Commission (EC) adopts a regulation that adjusts the fees payable to the Agency with reference to the inflation rate in the EU for the previous year. The 2018 inflation rate was 1.7%.

The EMA will publish full details of the revised fees at the end of March, once the regulation has been adopted by the EC and publish in the Official Journal of the EU. The Agency’s Management Board will decide on the implementation of the regulation at its March 2019 meeting.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.

Follow the link for full details:

EMA Website

First Guidance on New Rules for Certain Medical Devices

The EMA published the first in a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices.

The new regulations introduce new roles and responsibilities for the EMA and national competent authorities (NCAs) in relation to certain types of medical devices and in-vitro diagnostics. The Agency is working closely with the EU regulatory network and with stakeholders from the pharmaceutical and medical device industries, including notified bodies, to ensure a smooth transition to the new regulatory framework.

Follow the link for full details:

EMA Website

EMA now operating from Amsterdam

As of the 13th March 2019, the EMA is operating from Amsterdam. The EMA left its London premises on the 1st March, and following a transitional week of teleworking, its staff will gradually move throughout this week into the Spark building in Amsterdam Sloterdijk.

Follow the link for full details:

EMA Website

Notification of Request for a Time-Limited Exemption to Continue Batch Control Testing in the United Kingdom after their Withdrawal from the EU for a Nationally Authorised Medicinal Product

The CMDh has agreed a template for a “Notification of request for a time-limited exemption to continue batch control testing in the United Kingdom after their withdrawal from the EU for a nationally authorised medicinal product” to be used by Market Authorisation Holders. Details on the process to be followed have been included in the “Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP”. The practical guidance has further been updated to align it to the relevant document related to centrally authorised products, as far as possible, and to reflect recent CMDh agreements related to Brexit. All documents (communication from the European Commission, template to request batch control testing exemption and updated practical guidance related to Brexit) have been published on the CMDh website under “Brexit”.

Follow the link for full details:

HMA Website

Emerging Markets


The Drugs and Cosmetics (Third Amendment) Rules, 2013

The rules for ethics committees set forth the required composition of an ethics committee and list the information that must be included in the registration application, such as whether the committee has been audited or inspected and if so by whom. The CDSCO is to verify compliance with the rules governing ethics committees.

In order to streamline the submission of applications for registration of Ethics Committees and their examination, it has been decided to introduce a system of preliminary scrutiny of such applications at the time of their receipt to determine their acceptability for examination by the CDSCO.

Follow the link below for full details:

CDSCO Website


Brexit – Implications for Therapeutic Goods in Australia

Brexit ‘no deal’

Regarding medical devices, if there is a ‘no deal’ Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG.

For medicines, in the event of a Brexit ‘no deal’, there will be no impact on the supply of medicines to Australia from the UK. Under the UK-Australia MRA on Conformity Assessment, existing arrangements will continue whereby, the TGA will accept batch certification on MHRA Certificates for supply of medicines from the UK to the Australian Market.

Brexit ‘deal’ or exit extension

For medical devices, under the proposed Brexit ‘deal’, UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will be no immediate impact on manufacturers certified by these notified bodies.

For medicines, under the proposed Brexit ‘deal’, there will be no immediate impact on the supply of medicines to Australia from the UK. The existing arrangements will continue under the UK-Australia MRA as under the EU-Australia MRA. Similarly, if the timeframe for the exit of the UK from the EU is extended, current arrangements will continue, under the EU-Australia MRA, until an exit occurs.

Follow the link below for full details:

TGA Website

Share this page: