The Regulatory Times

June 2019

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


ANDA Submissions – Content & Format

There was a guidance previously published by the FDA on the filing process, including refuse-to-receive standards and common, recurring deficiencies which should be reviewed thoroughly prior to submission.

However, this guidance intends to identify the information that should be captured in each section of the common technical document (CTD) that an applicant should include to ensure a complete, high-quality application by referring to appropriate guidance and recommendations issued by FDA.

The applicant should ensure to provide necessary information in all these sections to support the application.

Module 1 – Administrative information and prescribing information

Module 2 – Summaries

Module 3 – Quality

Module 4 – Nonclinical

Module 5 – Clinical

This will enable the FDA to complete its review process in one review cycle provided an ANDA contains all necessary details.

For details please refer to the below link:

PDF Download

Electronic and Non-Electronic Format – Promotional Labelling and Advertising Materials for Human Prescription Drugs

The use of electronic submission of labels will help to increase review efficiency and improve the quality of labelling.

This guidance intends to provide more clarity on submissions of promotional materials of the electronic common technical document (eCTD), using version 3.3 or higher of the us-regional-backbone file.

The promotional materials collectively refers to promotional labelling and advertising materials, regardless of the format, manner, or medium by which they are presented. The submission of these promotional materials should meet a set of criteria in order to be reviewed by the agency. If the sponsor is submitting in paper copies, then paper copies of all promotional submission types will be accepted until 24 months following publication of this guidance. The sponsors needs to include one non-eCTD copy of the contents of the submission on a CD and include a statement in the cover letter verifying that the contents of the CD match the contents of the paper submission. As of that date, paper copies will no longer be accepted for such submissions. The sponsor will be required to submit electronically, and should follow specific procedures and meet conditions (leaf titles, use of operator attributes, etc.) to submit in eCTD format.

For details please refer to the PDF provided below:

PDF Download


One Additional Country to Benefit from EU-US Mutual Recognition Agreement for Inspections

On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories.

For more details, please refer to the link below:

EMA Website

Consultation on Draft Guideline on Quality Requirements for Medical Devices in Combination Products

The EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.

The guideline addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a CE (Conformité Européenne) certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body (NB) on the conformity of the device.

Stakeholders are invited to send their comments by 31 August 2019 to using the template provided.

The EMA will take into account comments received during the consultation, with a view to finalising the guideline before the regulation fully applies on 26 May 2020.

For more details, please refer to the PDF below:

PDF Download

Recommendations for the Implementation of the Exemptions to the Labelling and Package Leaflet Obligations in the Centralised Procedure

Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may (subject to measures they consider necessary to safeguard human health):

  • Grant an exemption to the obligation that certain particulars should appear on the labelling [immediate and/or outer] and in the package leaflet.
  • They may also grant a full or partial exemption to the obligation that the labelling [immediate and/or outer] and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

Below changes were done with this version: Clarifications on which labelling components are covered by Art.63 (update of sections 2.1 and 2.2), moving of information from section 3.3 as well as information on shortage from section 3.1 to section 2.2 and addition of more flexibility with regards to omission of particulars requests under Art.63.3 affecting small MSs where multilingual packs are used.

For more details, please refer to the PDF below:

PDF Download

Two Additional Countries to Benefit from U-US Mutual Recognition Agreement for Inspections

The European Commission confirmed that the quality of active substances produced in the Republic of Korea are in line with EU standards. South Korea joins Australia, Brazil, Israel, Japan, Switzerland and the US as countries outside of the EU that have been established as manufacturing active substances in an EU-equivalent regulatory system with sufficient rules for manufacturing practices.

For more details, please refer to the link below:

EMA Website

Emerging Markets


TGA Assessed Claim for Assessed Listed and Registered Complementary Medicines

The TGA has implemented the ‘TGA assessed’ claim for sponsors of assessed listed medicines and registered complementary medicines.

In response to the Medicines and Medical Devices Regulation Review (MMDR), the Government accepted a recommendation to allow sponsors to publish a claim that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA.

What is the TGA assessed claim?

The TGA assessed claim is a symbol and/or statement that indicates that a medicine has the efficacy for its indications (a medicine’s claimed purpose or health benefit) assessed by the TGA. It can only be used in accordance with the TGA’s authority.

The implementation of the TGA assessed claim is intended to:

  • support consumers to make better informed purchasing decisions by improving the transparency about whether efficacy claims for certain medicines have been independently assessed by the TGA
  • improve consumer awareness about the medicines regulatory framework and the different levels of assessment undertaken by the TGA
  • provide an incentive for product sponsors to improve the standards of evidence and extend the evidence base for certain medicines.

What medicines does it apply to?

Assessed listed medicines and registered complementary medicines which have undergone a pre-market assessment of efficacy by the TGA are eligible to use the TGA assessed claim on their medicine label and other advertising material. Prescription and over the counter (OTC) medicines will not display the TGA assessed claim.

Follow the link below for full details:

TGA Website

Sunscreen Manufacturing Demonstrating Compliance with the PIC/S Guide to GMP, PE009-13 v2.0, June 2019

This guidance is for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.

In Australia, many sunscreens are regulated as therapeutic goods because of their important role addressing public health issues. As such they must comply with the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and any other relevant regulatory requirements.

Sunscreens that are regulated as therapeutic goods under the Therapeutic Goods Act 1989 are referred to as ‘therapeutic sunscreens’. Included in this category are:

  • Primary sunscreens with SPF 4 or more
  • Secondary sunscreens – except those regulated as cosmetics

The following changes are proposed in this version:

  • Updates to reflect recent changes to TGA guidance material

Follow the link below for full details:

TGA Website

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