EGA publishes vision for more efficient regulation of generics and biosimilars

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On 27 October 2010 the European Generic medicines Association (EGA) published its Vision 2015 following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp, Belgium, 26 October 2010. The EGA is calling for changes in the regulatory requirements for generic and biosimilar medicines ‘for the sake of healthcare sustainability’.


The EGA Vision 2015 suggests improvements to the existing legal and regulatory framework to improve patient access to affordable treatments by:

  • enhancing the competitiveness of the generic and biosimilar medicines industry by creating a level playing field for global competition, harmonising GxP (good practice quality guidelines and regulations) practices and introducing a broader interpretation of the EU reference product;
  • maintaining competition and sustainable health care by preventing anti-competitive strategies aimed at delaying generic entry, rejecting patent linkage in regulatory processes and extending the Bolar provision to cover pricing and reimbursement;
  • improving patient access to affordable medicines through better regulation by increasing the role of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh); and streamlining the decentralised procedure, adapting the marketing authorisation procedure to the realities of the off-patent market, reducing bureaucracy through employing electronic interfaces and adopting a homogenous and consistent implementation of the revised EU bioequivalence guideline;
  • reinforcing regulatory harmonisation by removing country-specific requirements, building efficient marketing authorisation procedures through efficient use of resources, improving the mutual recognition of the assessment performed by one authority by other authorities to avoid a duplication of work , optimising work-sharing across Member States; and
  • providing patients with necessary and appropriate information by encouraging agencies to devote website space for information on generic and biosimilar medicines and preventing negative campaigns against generic and biosimilar medicines.

Today, generic medicines in Europe represent almost half of the pharmaceutical market by volume but account for only 18% of the total cost. Generic medicines already create savings of over Euros 30 billion and newly established biosimilar medicines contribute savings of Euros 1.4 billion per year to European healthcare systems.

In 2009 41% of generic applications were submitted via a centralised procedure, whereas 83% were submitted via a decentralised procedure. A more effective regulatory environment, enabling more generic applications to be submitted centrally, could increase the savings to European healthcare systems, and improve patient access to affordable medicines.

Related article

EGA wants better Centralised Procedure and Decentralised Procedure for generics authorisation

Source: EGA Press Release

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