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Jul 31, 2015

EMA to encourage use of Scientific Advice for Post-Authorisation Safety Studies
12-month pilot will support design of high-quality safety studies!

The European Medicines Agency (EMA) is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorisation safety studies (PASS) for medicines. This voluntary, optional procedure will help to improve the design of studies meant to collect further information on a medicine's safety once it is on the market. This pilot will build on the expertise of the Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

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FDA Draft Guidance on Metrics in Manufacturing
FDA released its draft guidance on metrics for manufacturing for comments within the next 60 days

Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be used by FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing. This guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

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Beat Widler authors article on Inspection Readiness
The German Society for Pharmaceutical Medicine published an article by Beat Widler on Inspection Readiness (in German)

Für Qualitätsmängel in der klinischen Forschung gibt es viele Ursachen. Sie machen die Forschung unkalkulierbar, teuer und bringen mitunter sogar das „Aus“, wenn die Mängel bei einer Inspektion aufgedeckt werden. Dabei sind klare Abläufe, eindeutige Verantwortlichkeit, zeitgerechte Entscheidungsfindung sowie ein formaler und dokumentierter Abschluss von Maßnahmen Garantien, dass Probleme bei der Qualitätssicherung rasch erkannt und effizient gelöst werden können, wie im Artikel ausgeführt.

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EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement the Procedure for accelerated Assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004
EMA provides further clarification on the accelerated assessment procedure

Based on the experience gathered by reviewing the approach taken to the assessment of past applications since the last version of the guideline in July 2006, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the justifications provided by the applicant that the medicinal product falls within the scope of the accelerated assessment.

The scope of this guideline is to provide applicants with guidance on the accelerated assessment request and the practical arrangements necessary to implement the legal provisions on the accelerated assessment procedure. It forms the basis for requesting an accelerated assessment, and should be followed unless otherwise justified. This guideline has to be read in conjunction with Notice to Applicants (Eudralex Volume 2), as well as other pertinent EU guidelines.

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EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use falling within the Scope of Regulation (EC) No 726/2004
This draft guideline has been updated in order to reflect the experiences accumulated with conditional marketing authorisations and is therefore released for repeated public consultation.

According to Article 14(7) of Regulation (EC) No 726/2004, following consultation with the applicant, an authorisation may be granted subject to certain specific obligations, to be reviewed annually by the Agency. The list of these obligations shall be made publicly accessible. By way of derogation, such authorisation shall be valid for one year, on a renewable basis. This provision for a conditional marketing authorisation is further defined in Regulation (EC) No. 507/2006. Conditional marketing authorisation, in line with the defined scope and criteria and in the interest of public health, is usually appropriate for products where benefit-risk balance is such that the immediate availability outweighs the limitations of less comprehensive data than normally required, i.e. medicines with an established potential to address an unmet medical need.

This guideline addresses granting and renewing a conditional marketing authorization, as well as granting of a marketing authorisation not subject to specific obligations following their completion. This guideline should be followed unless otherwise justified

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