Compendial Compliance

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

The agency published a guideline for the implementation of ICH Q3D.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

The agency now allows production of water for injection by non-distillation technologies.

The directorate is looking for experts to join the European Pharmacopoeia network.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

USP responds to FDA's draft guidance on the naming of biological products.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

Will biosimilars share a compendial identity like generic drugs do?

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

USP and ChP jointly host two-day meeting to strengthen cooperation.

USP releases compendium of quality standards for compounded medicines.

USP expresses its support for a consensus-based global approach to the naming of biologics.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.