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Apr 3, 2017

FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Drug Administration and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.

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New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017

FDA plans to issue quite a number of new regulations in 2017 among most notably a new guidance on post marketing safety reporting and adaptive clinical trial design.

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China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data

On Jul. 22, 2015, CFDA issued the Announcement of Self-Examination and Inspection of Drug Clinical Trial Data (No.117, 2015). According to the requirement of “the most rigorous standard, the most strict supervision, the severe penalization and the most serious accountability and to safeguard the food and drug safety of the broad masses of the people, CFDA conducted drug clinical trial data inspections for the registration applications of the 1622 pending productions or imported drugs. The inspection work for drug clinical trial data was henceforth started and until now, a whole year has passed.

According to spirit of the State Council’s Comments on the reform of the review and approval system of medical devices for drugs (state issue 2015 No.44), to improve the transparency and impartiality of the inspection work for drug clinical trial data, implements the three openness principles of open standards, open procedures and open results, the Center for Food and Drug Inspection of CFDA carefully summarized the on-site inspection work for clinical trials of all the involving drugs in announcement No.117.

More details can be found in the link provided below:

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EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Medicines where suitable alternative data are available can remain on market

The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for approval of generic medicines. The list of medicines recommended for suspension can be found here. The suspensions can be lifted once alternative data establishing bioequivalence are provided.

Alternative supporting data have already been provided for several of the medicines reviewed. Therefore, the CHMP recommended that these medicines can remain on the market. The list of medicines recommended to remain on the market is available here.

The Agency also recommended that medicines not yet authorised but which are being evaluated on the basis of bioequivalence studies from these sites should not be authorised until bioequivalence is demonstrated using alternative data.

Micro Therapeutic Research Labs is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU.

The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016. The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling.

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Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements

Pocket EDMS is a reference EDM implementation protocol for small sized companies. Pocket EDMS is based on a Universal Requirements Specifications set including, Users, System and Quality/Regulatory Requirements. It also includes a Q&A document (replacing the traditional RFI – Request for Information) and a set of notation tools allowing sponsor companies to easily evaluate vendor proposals.

In order to qualify for Pocket EDMS implementation, a package must provide capacity for Electronic Document Management including Quality documentation and Electronic Trial Master Files, with extensions to Publishing / ECTD and Regulatory Information Management. It must be priced according to the limited needs of small companies and be based on existing standards (EDM Reference Model, GMP Quality Systems Reference Model, TMF Reference Model…) as described in the Pocket EDMS specifications.

The Pocket EDMS Requirements Specifications are the result of collaboration from a large number of contributors. They are aimed at streamlining the implementation process by removing all the steps that do not constitute a field of differentiation between software packages. Thus, competition is limited to price and services offered by the participant vendors.

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