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FDA/EMA QbD Parallel Assessment Q&A

In mid-December, FDA and EMA began publishing a series of joint question-and-answer documents that outline the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application. The first one covers the level of detail expected in a QbD submission. FDA and EMA will publish additional question-and-answer documents on other QbD-related […]

Comments Requested on Revisions to Canadian Product Monograph

In mid-December, Health Canada requested comments on a revised draft of its product monograph requirements. The purpose of the revisions to the draft were to provide: ●restrictions on the reference section ●more clarity on comparator data expectations● more clarity on adverse reactions● more specificity with respect to pediatric data● streamlined toxicology reporting ● streamlined pharmacology […]

USP and Russia to Develop Quality Standards

In mid-December, USP held discussions with experts from the Russian Federation on collaborating on the development of drug quality standards. A press release from USP discusses how the International Training Program (ITP) is being utilized to create more quality regulatory personnel for Russia’s Federal Service on Surveillance in Healthcare.

EMA Veterinary Novel Therapies

In mid-December, EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) established an expert group on novel veterinary therapies. The expert group will work to provide guidance on the new classes of veterinary medicines, such as stem-cell therapies and monoclonal antibodies (MAbs). The group was formed due to the need for guidance on novel concepts […]

Canada Releases Harmonized Requirements for Batch Certification

In early December, Health Canada created an internationally harmonized batch certificate that allows importers to have necessary quality information on hand in case it is needed by companies or regulators.

Revised USP Chapters on Plastic Packaging

Issued in USP Pharmacopeial Forum 39(5) are new chapters and subchapters relating to the use of plastic packaging systems. New versions of chapter <661> and subchapters <661.1> and <661.2> discuss the selection of safe plastics with regard to extractables, leachables, and stability.

EDQM Launches New Standard Terms Database

In mid-November EDQM released a new version of its Standard Terms Database. Changes from the previous version include the addition of characteristics associated with different dosage forms, links between terms, and more complete histories of terms.

CDER MAPP for Chemistry Review of QbR Submissions

A Manual of Policy and Procedures (MAPP) for Chemistry Review of Question-based Review (QbR) Submissions was released in mid-November. The MAPP clarifies how reviewers in OPS should assess NDAs and ANDAs that follow a QbR format. The document lists the benefits that come from using a QbR approach, and in the appendix, the 62 questions […]

USP and ChP Host International Forum on Strengthening Cooperation and Recognition of Pharmaceutical Standards

In mid-November in Chengdu, China, USP and ChP hosted the International Forum on Strengthening Cooperation and Recognition of Pharmaceutical Standards. The forum included regulators from many other countries and focused on international coordination and mutual recognition of pharmaceutical standards in areas such as chemical medicine, biologics, traditional Chinese medicine, pharmaceutical excipients, and packaging materials.

New Chair of MHRA

MHRA announced in early November that Michael Rawlins would take over as Chair of the MHRA from Gordon Duff starting in December. Michael Rawlins was Chair of the U.K.’s National Institute of Health and Clinical Excellence (NICE) from 1999 until 2013, as well as President of the Royal Society of Medicine from 2012 to 2014.
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