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Nov 3, 2020

Providing Regulatory Submissions in Electronic Format — Standardized Study Data
On 29 October 2020 the FDA announced the availability of the final guidance for industry.

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA) has specified the electronic format for submitting certain submission types to the Agency, such content must be submitted electronically and, in the format specified by FDA. This guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically in a format that FDA can process, review, and archive.

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Referencing Approved Drug Products in ANDA Submissions
On 27 October 2020 the FDA announced the availability of the final guidance for industry.

This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission.

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Updated Guidance on Pharmacovigilance (PV) Procedures
On 27 October 2020 the MHRA published the updated guidance on PV procedures.

This document outlines the submission requirements for pharmacovigilance data beginning 1 January 2021.

The MHRA will retain responsibility for Pharmacovigilance across the UK beginning 1 January 2021. There will be different requirements for some products placed on the market in the UK with respect to Great Britain and Northern Ireland. Great Britain is comprised of England, Wales and Scotland. For products placed on the market in Northern Ireland requirements will, in general, remain in line with EU requirements as indicated below.

From 1 January 2021, for medicines authorized in Great Britain, the Marketing Authorization Holder (MAH) will be required to submit pharmacovigilance data to the MHRA, according to UK requirements, including:

  • UK and non-UK Individual Case Safety Reports (ICSRs)
  • Periodic Safety Update Reports (PSURs)
  • Risk Management Plans (RMPs)
  • Post-Authorization Safety Studies (PASS) protocols and final study reports

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Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
On 20 October 2020 the FDA announced the availability of the draft guidance for industry.

This guidance is intended for applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products under section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70. In other words, this guidance is intended for applicants that are required by statute or regulation, or that have agreed in writing, to conduct postmarketing studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements (PMRs) or postmarketing commitments (PMCs). This guidance describes the purpose and content of Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics; when to use these forms; and how to submit these forms. Submission of completed Form FDA 3989 will meet the reporting requirements for postmarketing studies or clinical trials described in section 506B of the FD&C Act and its implementing regulations.

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Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021
On 23 October 2020 the MHRA updated guidance on the QPPV and PSMF for UK authorized products.

From 1 January 2021, the following legal obligations will apply to holders of UK marketing authorizations (MA). These include those that cover the whole of the UK, or are specific to Northern Ireland or to Great Britain (England, Wales and Scotland), including Great Britain MAs granted to allow unfettered access from Northern Ireland.

  • To operate a pharmacovigilance system for UK authorized products.
  • To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates in the EU or the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorized products.
  • To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorized products. The PSMF must be accessible electronically from the UK at the same site at which reports of suspected adverse reaction may be accessed.

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Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population
On 22 October 2020 the EMA issued this reflection paper for medicine developers.

The reflections in this paper apply to any new application for a marketing authorization (MA) or variation to an existing MA, and for all application types including full and abridged MAs (i.e. new medicinal products, generics, well established use). Where appropriate, the reflections may be considered during the clinical trial phases and in the post-authorization phase as part of the product lifecycle management. To support the progression of scientific and regulatory knowledge in the development of medicines for older people / patient-centric medicines, users of this paper are encouraged to actively send feedback to EMA on the basis of their experiences applying the principles of this reflection paper.

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EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 19 October 2020 the EMA issued guidance revision 10 addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.

This guidance document provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request. This guidance document also explains the scope and nature of scientific advice and protocol assistance. It will enable Applicants to submit requests which are in line with Scientific Advice Working Party (SAWP) requirements and which can be validated and evaluated quickly and efficiently.

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Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products
On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.

The guideline applies to clinical development considerations for overseas-marketed and domestic-non-marketed reference products as well as generics. The clinical evaluation rationale covered in the guideline is based on clinical needs assessment, efficacy and safety evaluation and clinical trial requirement.

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