WSQMS Homepage


Dec 1, 2020

MHRA Updated Guidance on Pharmacovigilance Procedures
On 30 November 2020 the MHRA updated the guidance on pharmacovigilance procedures.

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

The MHRA will retain responsibility for Pharmacovigilance across the UK from 1 January 2021. There will be some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. Great Britain is 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

These will be assessed taking into account all relevant information and decisions will be made reflecting UK clinical practice to best support patient safety in the UK.

The Good Vigilance Practices (GVP) modules will remain in force but MHRA will publish a guidance note on the exceptions and modifications to the EU guidance on good vigilance practices in due course.

Read more online 

Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry
On 30 November 2020 the FDA published the draft guidance for industry. Submit comments by 26 February 2021.

Elevation of gastric pH by acid-reducing agents (ARAs) can affect the solubility and dissolution characteristics of orally administered drug products. As a result, concomitant administration of a drug with an ARA could alter the bioavailability of the drug, potentially resulting in a loss of efficacy for weak-base drugs or increased adverse events for weak-acid drugs. ARAs such as antacids, histamine H2-receptor antagonists (H2 blockers), and proton pump inhibitors (PPIs) are widely used, and many of these drugs are available over the counter. Consequently, there is an increased risk for clinically significant drug-drug interactions (DDIs) with concomitant administration of drugs with ARAs. Therefore, it is important to assess the susceptibility of an investigational drug to DDIs mediated by gastric-pH changes (referred to as pH-dependent DDIs) early in drug development, characterize the DDI effect with clinical studies when needed, and communicate the relevant findings in the drug product labeling.

Read more online 

On-site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials
On 26 November 2020 the UK MHRA published the new guidance for Sponsors, CROs and investigator sites.

This guidance is for Sponsors, Contract Research Organizations (CROs) and investigator sites when considering management of personal data processed in relation to research. It should be read in conjunction with the Heath Research Authority (HRA)/MHRA joint advice on Data Protection Impact Assessments (DPIAs). In this context ‘processing’ also means access to Electronic Health Records (EHRs).

Historically, monitors could be provided with the physical records of individual trial participants, without also providing them access to the records of other patients. Where EHRs have been designed to allow similarly restricted access, access may continue to be provided as it has been. Where EHRs do not have this functionality, additional safeguards are required.

Read more online 

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
On 24 November 2020 the FDA announced the availability of the final guidance for industry.

This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.

Read more online 

Qualification Process for Drug Development Tools
On 24 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

Section 3011 of the 21st Century Cures Act (Cures Act) added new section 507, Qualification of Drug Development Tools (DDTs), to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance meets the Cures Act’s mandate to issue final guidance on the section 507 qualification process. Specifically, this guidance represents the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on implementation of section 507 of the FD&C Act with respect to describing the process for requestors interested in qualifying DDTs and on taxonomy for biomarkers and other DDTs.

Read more online 

Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.

This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

Read more online 

Cross Labeling Oncology Drugs in Combination Regimens
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.

Drug approvals in oncology often build on treatment effects by adding drugs to current regimens or by combining investigational drug products in a combination regimen, creating new regimens with greater efficacy. Traditionally, applicants have not requested changes to the labeling of a previously approved drug to describe how to use that drug in a new regimen (cross labeling). However, there has recently been an increasing number of applications that have proposed cross labeling for oncology drug combination regimens. The purpose of this guidance is to describe FDA’s current recommendations about including relevant information in labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of these drugs. This guidance does not address all issues that might arise relating to labeling for oncology drugs for use in a combination regimen. Applicants proposing cross labeling for oncology drug combination regimens should contact the review division for information on cross labeling of their individual products.

Read more online 

Clinical Drug Interaction Studies with Combined Oral Contraceptives
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 22 February 2021.

This guidance is intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the need for drug-drug interaction (DDI) studies of their investigational drugs with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. This guidance focuses on evaluating the DDI potential of an investigational drug (i.e., perpetrator) on a COC (i.e., victim).

Read more online 

Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider
On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.

This document is intended to provide guidance on the steps to be followed during remote pharmacovigilance (PhV) inspections of marketing authorization holders (MAHs).

Remote inspections should follow the guidelines and procedures that already exist for coordinating, preparing and conducting PhV inspections, but should take into consideration the limitations imposed by using a remote process. It is the purpose of this document to outline the specificities of remote PhV inspections by identifying the points that should be considered during the preparation, conduct and reporting of such PhV inspections of marketing authorization holders (MAHs) with centrally authorized products (CAPs) and national authorized products (NAPs).

Read the pdf 


You receive this newsletter, because you have subscribed to it.
If you no longer want to receive this newsletter, you can easily leave the list at this Website. You can't view the images in this e-mail? Click here to open it in your browser.

Widler & Schiemann AG - Baarerstrasse 75 - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -