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Ph. Eur. Establishes General Methods Working Party

In late February, the European Pharmacopeia (Ph. Eur.) designated a new working party to be in charge of general methods. The group will track new trends and technologies and report on them. These reports will be used to help decide when existing texts and monographs need revision.

Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan

Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management....

Mandatory EMA Electronic Applications

Starting July 1, EMA will only accept electronic applications for initial marketing authorisations, variations, and renewals for human and veterinary drugs. Next January, applications in Word format will no longer be filable and only eCTD versions of the electronic application will be accepted. These measures are designed to reduce administrative burden, while also improving data […]

EMA Weekly Start Dates for Type II Variations

Beginning in March, EMA announced it would introduce weekly start dates to facilitate the assessment of type II and worksharing variation applications. This change is expected to provide more flexibility and streamline the assessment process.

EMA Drug Identification Implementation

EMA announced the establishment of a task force for implementing international standards for the identification of medicinal products (IDMP) in early February. The task force creation follows from the finalization of ISO IDMP standards in 2012. Implementation guidelines are expected to be available in 2016.

European Medicines Verification Organisation Established

In mid-February, EFPIA, along with EGA and EAEPC, announced the establishment of the European Medicines Verification Organisation (EMVO). EMVO is designed to provide end-to-end verification of drugs from manufacture, through distribution to patients by creating an infrastructure for complying with EU’s Falsified Medicines Directive.

Concept Paper on Revision of GMP Annex 1

A concept paper on revisions to EMA’s GMP Annex 1 on the manufacture of sterile medicinal products was published in early February. The concept paper proposes incorporating changes resulting from the adoption of ICH Q9 and Q10 as well as changes made in other EU GMP chapters.

Revised MHRA GMP Requirements for “Specials” Manufacturers

In late January, MHRA published a revised guidance on the GMP requirements for “specials” manufacturers – those who make product without a marketing authorization, similar to a compounding pharmacy in the U.S. The guidance consists of an introduction, scope, Q&A section, glossary, reference documents, and revision history. An appendix is included listing the updates to […]

Minor Changes to GMP Chapters 3 and 5

Minor changes to EU GMP chapters 3 and 5 were made in late January. Added were transitional arrangements for toxicological evaluation that come into effect in March.

EMA Searchable EudraLex

In late January, EU introduced a downloadable and searchable version of its Eudralex listings on pharma legislation. Eudralex V30 can be used offline and contains pdf versions of all legislation listed online.
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