WSQMS Homepage


Jan 7, 2019

New FDA draft guidance on in-vitro companion diagnostics
FDA issues new guidance on Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products

This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as “companion diagnostics” herein) to support the indicated uses of multiple drug or biological oncology products, when appropriate. This guidance expands on existing policy, surrounding broader labeling (i.e., labeling that is expanded), which notes that in some cases, if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group or class of therapeutic products, the companion diagnostic’s intended use/indications for use should name the specific group or class of therapeutic products, rather than specific products. The specific group or class of oncology therapeutic products would be identified for this purpose based on sufficient and consistent clinical experience with the therapeutics with the same approved indications, including mutation(s) and disease, for which a companion diagnostic could potentially be labeled (as discussed in this document). To describe FDA’s current thinking on this topic, the guidance discusses a specific example, companion diagnostics that identify patients with non-small cell lung cancer (NSCLC) whose tumors have the most common epidermal growth factor receptor (EGFR) mutations, exon 19 deletions or exon 21 (L858R) substitution mutations.

Read the pdf

China: New NMPA guidance on Marketing Authorization Holder (MAH) to report adverse events
NMPA (former CFDA) released “Guideline for the collection and reporting of individual drug adverse events” on 21, December, 2018

Illustrated that the gathering and reporting of adverse events are the fundamental pharmacovigilance (PV) activities, the guideline specified MAH’s legal responsibility of Individual Case Safety Reporting (ICSR) to the regulatory authorities. MAH should establish an effective information management system to analyze adverse events information gathering from physicians, pharmacists, and patients within medical institutions, distribution channels, and customer relations platforms. MAH should also proactively identify and collect any adverse event information appearing in academic literatures, clinical research, marketing projects, and social media. After receiving ICSRs (including those from the regulatory authorities), MAH’s PV department should process and assess the data, identifying new or increased risks and developing Integrated Safety Management Plan (ISMP).

Issued by NMPA, REF [2018] No.131

Read more online

China to implement faster approval system for imported drugs
NMPA issued the regulation on “Application and sample requirements for product specification evaluation of imported drugs” for public comment from 19, DEC, 2018 to 18, JAN, 2019.

This document provides application and sample requirements for product specification evaluation of both chemical drugs and biological products.

The application requirements including analysis and verification methods, formulation and manufacturing procedures, manufactured products’ inspection reports, CoAs of reference substances, APIs, and excipients, and stability analysis reports. All information needs to be provided in both hard copies with official chop and soft copies.

As for the samples, requirements including that the sample size should be at least three times of the amount as for the Full Product Analysis, the product should achieve commercial batch size with expiry date no less than six months, and the sample information should be consistent throughout the application. Reference substances for analysis and any materials that are not listed in the latest Chinese Pharmacopeia should also be provided.

Issued by NMPA on 19 DEC 2018

Read more online

EMA note to guidance on manufacture of finished dosage form
Clarification on the type and level of information that should be included in the marketing authorization

This Note for Guidance provides guidance on the background and the interpretation of some aspects of the text of the directive. This Note for Guidance does not pertain to biological medicinal products such as vaccines, sera, toxins and allergens, products derived from human blood and plasma as well as medicinal products prepared biotechnologically.

Concerning the application of Part 2, section B of the Annex to Directive 75/318/EEC, as amended by Directive 91/507/EEC, with a view to the granting of a marketing authorization.

Read the pdf

Recent developments in EU Pharmacovigilance, relating to medicines for human use,

The latest EMA QPPV update December discusses several topics:

Pharmacovigilance IT systems, Processes, Guidance and Dialogue as well as an update on EMA’s Brexit preparedness.

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 - Weinberghöhe 10 B - 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 - -