The Regulatory Times

June 2018

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

US

Draft Guidance for Industry

Assessing User Fees Under the Prescription Drug User Fee Amendments (PDUFA VI) of 2017

This guidance is intended to assist applicants with respect to user fee structure, and types of fees for which entities are responsible.

This guidance describes on types of user fees, the process for submitting payments, the consequences for failing to pay application fees or prescription drug program fees, and the process for requesting a reconsideration of a user fee assessment.

FDA has separate guidance documents about PDUFA VI waivers, refunds, and reductions. This guidance does not address how FDA determines and adjusts fees each fiscal year; nor does it address FDA’s implementation of other user fee programs (e.g., Biosimilar User Fee Amendments, Generic Drug User Fee Amendments).

This guidance is effective from May 2018.

For details please refer link provided below: 

PDF Download

Guidance for Industry

Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This guidance is intended to assist applicants about to FDA’s definition of outsourcing facility, which is involved in compounding of drug products.

As per section 503 the outsourcing facility should complies with CGMP regulations, and the facility may be comprised of one or multiple suites within a single building, or one or multiple buildings at one geographic location or address. Further, a geographic location could include two or more addresses, provided that FDA is capable of inspecting the addresses within a single inspection.

This guidance is effective from May 2018.

For details please refer link provided below: 

PDF Download

Draft Guidance for Industry

Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act

This guidance is intended to provide recommendations for how trading partners and stakeholders should request a waiver, exception, or exemption from the requirements of section of the FD&C Act, and describes the review process at FDA and decision on such requests and determine FDA-initiated exceptions and exemptions. Additionally, this guidance describes how FDA intends to biennially review and renew waivers, exceptions, and exemptions.

This is a draft guidance and the applicants could be followed for such requests in future.

For details please refer link provided below: 

PDF Download

EU

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This guideline provides the following updates:

  • Procedure number for grouped variation applications for one or more products
  • Changes covered under the company’s quality assurance system that do not require a variation to the Marketing Authorisation
  • Impact of new equipment in the manufacturing process
  • Submission requirements for article 46 paediatric study application

For Details, please refer below link:

PDF download

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

This guidelines suggest the following updates:

  • Allocation of EMEA application/ Procedure number
  • Guideline on multipack presentation

For Details, please refer below link :

PDF download

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This guideline provides the following updates:

  • Procedure number for grouped variation applications for one or more products
  • Changes covered under the company’s quality assurance system that do not require a variation to the Marketing Authorisation
  • Impact of new equipment in the manufacturing process
  • Submission requirements for article 46 paediatric study application

For Details, please refer below link:

PDF download

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

This guidelines suggest the following updates:

  • Allocation of EMEA application/ Procedure number
  • Guideline on multipack presentation

For Details, please refer below link :

PDF download

EM-APAC

Australia

Child-resistant packaging requirements for medicines – Guidance on TGO 95 – Version 1.0 May 2018

This guidance explains the agency’s requirements for child-resistant packaging (CRP). These requirements apply to prescription, over-the-counter (OTC) and listed medicines. This guidance replaces the previous Guidance on Therapeutic Goods Order No. 80 (TGO 80) Child-resistant packaging requirements for medicines.

The purpose of this guidance is to set requirements for the packaging of medicines that present a significant risk of toxicity to children if accidentally ingested. These requirements describe packaging that is designed to be resistant to opening by children, thereby reducing the incidence of accidental poisoning.Transition period: TGO 80 will cease to exist (sunset) on 1 October 2018. At the end of the transition period, all medicines supplied in Australia to which TGO 95 applies, must comply with the requirements of TGO 95.

For Details, please refer below link:

TGA website

Guidance for completing the application for evaluation of a substance for use in listed complementary medicines – Version 1.1 April 2018

This guidance is intended for applicants applying to vary a determination made under section 26BB of the Act (the Therapeutic Goods (Permissible Ingredients) Determination).

Following updates are done with this version:

  • Updated name of document from “Guidance for completing the application for a new substance for use in listed complementary medicines”
  • Updated hyperlinks
  • Included notes regarding COR report-based process
  • Included information regarding exclusive use of new approved ingredients

For Details, please refer below link:

TGA website

Australian regulatory guidelines for complementary medicines (ARGCM) – Version 8.0 April 2018

The following updates have been provided in this version:

  • Amended to incorporate legislative changes for substance evaluations.
  • Title changed from ‘New complementary medicine substance evaluation’ to ‘Evaluation of a substance for use in listed complementary medicines’.
  • ‘New complementary medicine substance’ changed to ‘substance for use in listed complementary medicines’ throughout document.
  • References to the form ‘Application for evaluation of a new complementary medicine substance’ changed to ‘Application for evaluation of a substance for use in listed complementary medicines’.
  • Information in overview amended to clarify that applications for substances are made under 26BE the Act.
  • The following new sections have been included:
    • Application categories for evaluation of substances
    • Timeframes and fees
    • Exclusive use of new approved ingredients
  • Information on safety data page count removed from the section entitled ‘Phase 2: Lodgement of application’.
  • Section on ‘Clarification of information’ changed to ‘Requests for information’ and information reviewed to provide clarity on timeframes.
  • Information on sponsor’s ability to appeal decisions included under ‘Phase 5: Delegate determination’. Minor updates to Chart C1 e.g. include information on market exclusivity.
  • Table numbering amended to be consecutive C1 to C5.
  • Table C2 (renamed C4) moved up higher in document.

For Details, please refer below link :

TGA website

Publishing Updates

Health Canada – Considering for mandatory eCTD requirement for Master Files (MF’s) from January 1st, 2019

Health Canada is initiating a 90 days consultation period to solicit feedback regarding this proposal. Questions or comments regarding this Notice must be sent to hc.ereview.sc@canada.ca by August 10th, 2018.

Requirements for Master Files prepared in eCTD format

  • Prior to filing a MF in eCTD format a sample according to the eCTD and “non-eCTD electronic-only” guidelines must be provided to Health Canada, regardless of a company’s experience with using eCTD format.
  • A Pre-technical meeting is recommended for company’s using eCTD for the first time and is mandatory for MF s Type II and III.
  • After a sample has been approved and a pre-technical meeting has been conducted (for MFs Types II and III) a Dossier Identifier must be requested via email to hc.ereview.sc@canada.ca. The request should include a fully completed MF application form.
  • Once a sponsor files a MF in eCTD format, all additional information and subsequent transactions (such as updates, letters of access ( LOA), response to clarification requests, etc.) must also be filed in eCTD format.
  • All MF transactions must be sent via the CESG. MF Holders are strongly advised to obtain CESG accounts as soon as possible.

MF Holders may also convert their existing MFs from non-eCTD to eCTD format as per the requirements listed above.

As a baseline requirement when converting MFs from non-eCTD format to eCTD format, the MF Holder must include the entire MF in their first eCTD transaction. It is not sufficient to convert the MF into eCTD format by simply submitting the next transaction in eCTD via the CESG (i.e., submitting an LOA or an Update in eCTD format as a subsequent transaction for an MF currently in non-eCTD format).

For Details, please refer below link :

Health Canada website

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2018-08-13T15:42:10+00:00