The Regulatory Times

July 2018

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

US

Final Guidance for Industry Bioanalytical Method Validation

The final guidance, published in May 2018, has been updated to incorporate public comments to the 2013 revised draft and to reflect scientific and technological advances in the validation of bioanalytical methods.  The guidance is applicable to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologic license applications (BLAs).  The guidance applies to bioanalytical procedures that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation when used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies.

This guidance can also be applied to the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data.

Follow the link for full details:

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Draft Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

The procedural guidance published in June 2018 provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants, relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).  This guidance supercedes the now withdrawn guidance, Formal Meetings Between the FDA and Biosimilar Product Sponsors or Applicants, published in November 2015.

This guidance discusses the principles of good meeting management and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings with the Agency.

Follow the link for full details:

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EU

Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 1 June 2018

The USFDA confirmed the capability of two additional EU Member States i.e. Lithuania and Ireland to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 14 Member States whose inspection results the FDA can rely on to replace their own inspections. Mutual advantage for EU authorities and the FDA include prevention of duplicate inspections.

Follow the link for full details:

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CMDh procedural advice on changing the Reference Member State

The guideline highlights that for changing the Reference Member State of new marketing authorisation application, variation, renewal etc., all the procedures in the current RMS must be closed. Worksharing procedure is highly recommended for upcoming variations for harmonization. If several MAHs included in an MRP/DCP, then MAH in the current RMS should apply for the switch.

Follow the link for full details:

PDF download – clean

PDF download – tracked changes

Harmonised warning for ferrous sulfate-containing medicinal products1 on dysphagia and related bronchostenosis due to risk of aspiration

Following the publication of a harmonised wording to be included in section 4.4 and 4.8 of the SmPC (and the corresponding text for the package leaflet) of ferrous sulphate-containing tablets, the CMDh specifies that the CMDh recommendation concerns all medicinal products within ATC B03A A07 “ferrous sulfate”, except oral liquids.

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EU ASMF number request form

This request form should be used for an ASMF to be assessed as part of a new marketing authorisation through the Centralised or Decentralised procedure only, where a full assessment report will be prepared by a Competent Authority. Where the ASMF holder already holds an ASMF that has been assigned an EU/ASMF reference number and wishes to register another ASMF for the same active substance, e.g. a substantially different route of synthesis, this should also be clearly stated in the Additional information field.

Follow the link for full details:

CMDh website

Best Practice Guide for Decentralised and Mutual Recognition Procedures

The CMDh has updated the Best Practice Guide for Decentralised and Mutual Recognition Procedures. The Best Practice Guide is brought in line with other guidance documents, e.g. SOP on DCP and the MRP timetable, and it clarifies that the procedure start for MRP/RUP should also be communicated via email (in addition to communication via CTS). Further editorial changes have been included. The updated document is published on the CMDh website.

Follow the link for full details:

PDF download – clean

PDF download – tracked changes

Decentralised Procedure – Requests to act as RMS

The Heads of Medicines Agencies’ Task Force on Resources in DCP in cooperation with CMDh has developed a common request form to be used when asking a National Competent Authority (NCA) to act as Reference Member State in a decentralised procedure. The request form (http://www.hma.eu/219.html) should be submitted to the NCA in accordance with information provided by that NCA.

Follow the link for full details:

PDF download

Preliminary Renewal Assessment Report Template

A new template has been published by CMDh for the preliminary assessment of renewals submitted through MRP. This template shall be used by RMS to check that the products are still in compliance with the current requirements regarding quality and benefit-risk assessment. Based on the conclusion, RMS may grant unlimited validity or five-year validity as applicable.

Follow the link for full details:

CMDh website

EM-APAC

Australia

Regulatory requirements for in-house IVDs – Version 2.1 May 2018

The In-vitro diagnostic medical devices (ICD’s) which are manufactured In house by Australian laboratories are known as In-house IVDs. These labs are required to meet regulatory requirements to legally supply Inhouse IVDS to Australia. The transition period for compliance with the in-house IVD framework ended on 30 June 2017.

The current version is updated to remove transition information which ended July 2017 and include more information about what constitutes an in-house IVD.

Follow the link for full details:

TGA website

Medicine labels: Guidance on TGO 91 and TGO 92 – Version 1.1 May 2018

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders. There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they’re used.

In recognition of this, medicine label requirements are specified in two separate labelling Orders:

  • Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
  • Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92)

Following updates are done with this version:

  • Corrections based on feedback and clarification of existing information.
  • Addition of latex labelling in best practice – part 3.
  • Addition of guidance on determining when a Schedule 1 substance is present – part 1.

Follow the link for full details:

TGA website

Inhalation and nasal spray registered medicines – Application pathways & data requirements for registration of new generic medicines and variations to existing medicines – Version 2.2 May 2018

This guidance applies to inhalation and nasal spray medicines that are any of the following: metered-dose asthma inhalers or nasal corticosteroids or prescription medicines.

This guidance does not cover the following dosage forms: nasal drops or sublingual drops or medicinal gases.

Following updates are done with this version:

  • Title and scope changed
  • Removed guidance irrelevant to new scope
  • Increased information about application pathways
  • Clarified how to establish therapeutic equivalence
  • Restructured to increase readability

Follow the link for full details:

TGA website

Publishing Updates

Reminder: the transition period for current Australian regional specification ends 30 June 2018

The transition period for the current Australian regional specifications and validation criteria ends on 30 June 2018.

From 1 July 2018 the following specifications and validation criteria must be used to ensure successful validation of each sequence:

eCTD format

  • eCTD Version 3.1 File downloads and checksums
  • Australian eCTD regional specification and validation criteria version 3.1 excel spreadsheets.

NeeS format

  • NeeS Version 2.0 File downloads, which includes a new NeeS envelope form
  • Relevant eCTD Version 3.1 file downloads
  • Australian eCTD regional specification and validation criteria version 3.1 excel spreadsheets.

Follow the link below for full details:

TGA website 

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2018-08-13T15:41:18+00:00