Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Specific requirements of the new Pharmacovigilance legislation on the development and compilation of a dossier for a generic medicinal product (new application and life cycle management acitivities)
Jochen Bierlein (Abschlußjahr: 2013)
Summary
Language: English
Pharmacovigilance measures under the Austrian Medicines Law after Directive 2010/84/EU: An enhanced framework for transparency and product safety in (generic) medicinal products
In December 2010 the new pharmacovigilance legislation Regulation (EU) 1235/2010 (EU) and Directive 2010/84/EU was adopted by the European Council and European Parliament.
The legislation was the biggest change to the regulation of (generic) medicinal products for human use in the EU since 1995. It had significant implications for MAHs and MA of the EU Member States. The EMA was responsible for implementing much of the new legislation, which had been effective since July 2012.
The legislation was accompanied by the implementing regulation. On 19 June 2012 the implementing regulation No 520/2012 was published by the European Commission a legally binding act that provided details on the operational aspects for the new legislation:
Directive 2010/84/EU elevates the post-authorisation safety monitoring of (generic) medicinal products from the national to the European level. The objective of these measures is to enable speedier and more effective implementation of safety measures across the entire EU, as well as quicker recognition of possible pharmacological risks.
A generic medicinal product would be a medicinal product which had the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence (replaceability) with the reference medicinal product (same active substance, but not necessarily identical exipients. So, the both may differ in the colour) had been demonstrated by appropriate bioavailability (amount/time: assimilation/disposability of substance from (generic) medicinal product) studies [REG (EC) No 726/2004 Art 10(2)(b)]. Citation from Guideline on good pharmacovigilance practices (GVP) Annex I EMA/876333/2011 Rev. 1, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129131.pdf
EU Regulation 1235/2010 and Directive 2010/84/EU, both adopted on 15 December 2010, prescribe modifications to the relevant laws of EU member states. These modifications amount to a sea change in the safety monitoring of medicinal products for human use. They deal principally with pharmacovigilance processes, and as such have implications not only for EU marketing authorisation holders (hereafter “MAHs”) but also for the European Medicines Agency (EMA) as well as the regulatory authorities of the member states.
The stated goal of the 2010 pharmacovigilance legislation is to promote and improve the safety.
Its main task will be improve and promotion of the safety of (generic) medicinal products which have been placed into circulation, by harmonising the regulation of such products across all member states. Directive 2010/84/EU elevates the post-authorisation safety monitoring of (generic) medicinal products to the European level, enabling faster, more effective implementation of safety measures across the entire EU, as well as quicker identification of possible pharmacological risks.
The law clearly allocates responsibilities among the principal stakeholders, i.e. MAHs, the EMA, and national competent authorities. This facilitates the introduction and continual improvement of benefit-risk evaluations, and ensures that national regulatory authorities can implement safety measures more quickly and in coordination across the entire EU. (Generic) medicinal products approved at the EU regulatory level are covered by Regulation 1235/2010, while (generic) medicinal products approved at the member-state level, or by means of Mutual Recognition Procedure (MRP), are covered by Directive 2010/84/EU.
Both halves of the 2010 legislation were implemented in July of 2012
Together, they provide the legal foundation for assigning accountability and delegating responsibilities in the field of pharmacovigilance. An EU Directive mandating transposition into national law was necessary, as Regulations enacted by the EU are considered “supranational” and as such are binding upon the member states. The Directive itself, as well as the time frame for its required transposition, were published in the Official Journal of the EU. Each member state was required to take up the integration of Directive 2010/84/EU into its legislative code by 21 July 2012.
In Germany, the Directive necessitated modifications to the German Medicines Act (AMG).
As they had been presented in the form of a bill on 2 December 2011, these modifications took some time to codify. MAHs must plan the implementation of a Pharmacovigilance system master file/PSMF since the new EU PV legislation was put into force. It would cover sections describing the pharmacovigilance system that proved the compliance with the new PV requirements.
Information regarding the QPPV, databases, organisational structure of the company, processing of safety data, the quality system and description of the used computerised systems must be described. The PSMF must be continuously maintained in order to stay compliant. Several solutions must be found such as storing, preparing, and maintaining (paper- or web-based) to ensure access (online PSMF solutions via web at all time).
Pages: 49