The Regulatory Times

August 2018

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


ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA

This guidance provides insight to sponsors about review goals which was established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) and applies to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA.

GDUFA II has simplified the amendment review goals and no longer subjects them to a Tier system; however, GDUFA II review goals are still dependent on several factors, like whether the ANDA or PAS is subject to standard review or priority review and whether the amendment is classified as major or minor. Further, the review goals consider whether the submission require a preapproval inspection, and if a priority submission does require a preapproval inspection, whether the applicant submitted a timely, complete, and accurate pre-submission facility correspondence (PFC).

This final guidance supersedes the December 2001 Guidance for Industry Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications, Rev 2 and the July 2014 Draft Guidance for Industry ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA, both of which will be withdrawn.

Follow the link for full details:

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Innovative Approaches for Nonprescription Drug Products

This guidance suggests two new approaches to Applicants of non-prescription drugs, where the  mandatory drug facts labeling (DFL) information alone may not be sufficient to assure the safe and effective use of the drug in a nonprescription setting.

Additional labelling options that the FDA may approve include additional information leaflets contained within the drug product carton, video dispays of text or images, including interactive displays or statements or questions in a mobile app.

Additional Conditions that may be proposed by Applicants include requirements for consumers to affirm that they have viewed a video describing the appropriate use of the drug, or for consumers to complete a questionnaire on a mobile app which will determine their appropriateness for the non-prescription drug.

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EMA Identifies gaps in industry preparedness for Brexit

A recent survey carried out by European Medicines Agency (EMA) found that some companies need to step up efforts to ensure that medicine supplies in the UK and EU are not disrupted after Brexit.

It was found that Marketing authorisation holders for more than half (58 percent) of the 694 centrally authorised products were on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union. However, the survey found that for 108 (88 human products and 20 veterinary products) medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.

EMA urges companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible and to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.

Follow the link for full details:

EMA website

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

The CMDh has published on 19th June 2018 an update of the Q&As related to the United Kingdom’s withdrawal from the European Union with regard to national authorised medicinal products for human use. The Q&As are in line with the Q&As published on the EMA website for centrally authorised medicinal products. The related notice to MAHs of national authorised medicinal products for human use has also been updated.

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Emerging Markets


Changeover to Therapeutic Goods Advertising Code 2018 – 1 July 2018

The Therapeutic Goods Advertising Code 2015 (2015 Code) was amended on 29 June 2018. The only change was to the Schedule 3 (Pharmacist Only) Medicines statement (paragraph 6(3)(e)) to provide advertisers with the choice of using one of two statements:


when advertising medicines that are included in Schedule 3 of the Poisons Standard.

Advertisers should note that only statement (ii) will be acceptable when the 2018 Code comes into effect (i.e. from 1 January 2019).

Follow the link below for full details:

TGA website 

New Zealand

Schedule of Fees Payable under the Medicines Act 1981 – Effective from 1 July 2018

The new fee effective from 1 July 2018 is applicable. Staggered payment ption of New Medicines Application (NMA) Fees is available where applicants can opt to pay the total fee at once or in two parts. The selection should be made clear on the relevant application form. For the two part option, the initial fee can be paid when the application is submitted, with the balance to be invoiced by Medsafe in January 2019. This option is only available until 31 December 2018.

Follow the link below for full details:

Medsafe website 

Publishing Updates

Updated eSubmission Gateway XML delivery file user interface is available now

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional business rule to help users correctly select PASS 107 procedures types. Also, a Purchase Order number attribute for PASS 107 procedure was introduced.

Follow the link below for full details:

EMA website 

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