The Regulatory Times

February 2019

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


Draft Guidance for Industry Quality Considerations for Continuous Manufacturing

This draft guidance encourages applicants to adopt specific or unique scientific and regulatory considerations for continuous manufacturing. The continuous manufacturing is an intergrated process that consists of a series of two or more unit operations. These considerations include process dynamics, batch definition, control strategy, pharmaceutical quality system, scale-up, stability and bridging of existing batch manufacturing to continuous manufacturing.

This emerging technology would provide potential benefits to both industry and patients. For example: using an integrated process with fewer steps, supporting an enhanced development approach i.e., quality by design (QbD) , use of process analytical technology (PAT), models enabling real-time product quality monitoring, providing flexible operation to allow scale-up, scale-down and scale-out to accomodate changing supply demands techniques would enable industrialists to reduce drug product quality issues and improve availability of quality medicines to patients.

For details please refer to the link provided below:

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EMA launches checklist to facilitate validation for initial marketing authorisation applications

A survey launched by the EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications (MAAs). They create additional workload for companies and potential delays at a critical moment for the timely start of the procedure. To make the validation process more efficient, predictable and easier to navigate, EMA is encouraging applicants to submit package new validation checklist (Please refer the checklist given below) as part of the MAA dossier.

The initiative is launched as a five-month pilot and is expected to increase the number of ‘first time right’ submissions significantly.

Applicants who use the checklist are invited to submit their comments to EMA will use this feedback and the information collected on the quality of submissions using the new checklist to improve the validation process itself.

Follow the link for full details:

EMA Website

NEW – QRD form for submission and assessment of user testing bridging proposals

A new QRD form has been developed by CMDh to provide guidance and facilitate the submission of user testing bridging proposals by applicants as well as to facilitate the assessment by the RMS.

All sections of this form should be completed by applicants and submitted for assessment when applying for bridging.

The existing CMDh guidance “Consultation with Target Patient Groups: meeting the requirements of Article 59(3) without the need for a full test – Recommendations for bridging” will be revised in the near future to reflect the use of the form.

Follow the link for full details:

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“Blue-Box” requirements (CMDh/258/2012/Rev. 15)

This guidance provided additional information on a labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of Directive 2001/83/EC. These requirements apply to products authorised via a National, MRP, DCP only.

Follow the link for full details:

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Public consultation on key principles for the electronic product information of EU medicines

EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) have launched six-month public consultations on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will be developed and used in the European Union.

Stakeholders and members of the public are invited to submit comments on these key principles via an online form until 31 July 2019.

The link of draft guidance for public consultation is given below:

EMA Website

The product information (PI) of a medicine in the EU includes the package leaflet for patients an the summary of product characteristics (SmPC) for healthcare professionals.

For details, please refer to the below link:

EMA Website


CMDh Published Questions & Answers related to the United Kingdom’s withdrawal from the European Union with regard to national authorised medicinal products for human use

This list of questions and answers complements the notice to stakeholders on the withdrawal of the United Kingdom and EU rules for national authorised medicines products for human use, which was updates on the 1st of February 2019.

This list of Q&As addresses a situation where the United Kingdom becomes a third country on the 30th of March 2019 (‘the withdrawal date’) without a withdrawal agreement and hence without a transition period provided for in the draft withdrawal agreement.

Download the PDF below for full details:

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CMDh Best Practice Guide for the authorisation of non-prescription medicines in the decentralised and mutual recognition procedures (CMDh/250/2012 Rev. 1)

This guidance document aims to improve the functioning of MRP/DCP for authorising non-prescription medicines. It provides information about best practice MRP/DCP procedures as well as details of approaches to managing non-prescription medicines within the MRP/DCP system, in order to inform all NCAs and Marketing Authorisation Holders (MAHs) of the options available. Guidance is also given on the role of the Reference Member State (RMS) specific to procedures involving a Non-Prescription medicinal product. This guidance is additional to the CMDh Best Practice Guide for the Decentralised and the Mutual Recognition Procedures, which applies to applications for both medicinal products subject to medical prescription (Prescription-Only) and Non-Prescription medicinal products.

Anne 1 additionally addresses points to consider for reclassification from prescription-only to non-prescription of a medicinal product authorised through MRP/DCP

Follow the link for full details:

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EMA relocation updates

The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019. The Dutch authorities have already officially handed over the temporary building, the Spark building in Amsterdam Sloterdijk, to the EMA’s Executive Director Guido Rasi on the 9th of January 2019 and the EMA is now preparing for its physical move. Whilst relocating, the Agency has to ensure the continuation of its main activities throughout the move and has implemented phase 4 of its business continuity plan (BCP) accordingly. The focus will be on the authorisation, maintenance and supervision of medicines, on-going Brexit preparedness/implementation activities and preparing for the implementation of the new veterinarylegislation (highest priority – category 1 activities).

Follow the link for full details:

EMA Website

New safety features for medicines sold in the EU

As of the 9th of February, most prescription medicines and some over-the-counter medicines for human use supplied in the EU are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. The anti-tampering device is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.

These mandatory safety features are a key measure of the Falsified Medicines Directive which is part of the EU’s strategy to strengthen the security of the supply chain of medicines. The safety features are implemented through a delegated regulation that comes into application on the 9th of February 2019. It will apply in all EU/EEA Member States, except for Greece and Italy, who have until 2025 to update their already existing tracking systems.

Follow the link below for full details:

EMA Website


Emerging Markets


Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances

Amendments to the Therapeutic Goods Regulations 1990 came into effect in late November 2018 that allow discretion to reduce application and evaluation fees for a major variation application and evaluation fees for a major variation application in exceptional circumstances.

In order to be eligible, sponsors need to meet all eligibility criteria. The fee reduction is only intended for safety related changes in certain circumstances.

The eligibility criteria are captured in regulation 45(5):

  • The application is made under S23 of the Therapeutic Goods Act 1989

  • The medicine is of a kind of specified in Part 1 of Schedule 10

  • Apart from the directions for use the medicine is the same as another that is included in the register

  • The differences in directions for use or dosage model are necessary to ensure the safe use of the medicine

  • Evaluations of non-clinical or quality data is not required for registration

  • Information relating to the medicine enables preliminary assessment and evaluation of the medicine to be abridged


Follow the link below for full details:

TGA Website

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