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November 26, 2013

With over 30 years’ experience in regulatory affairs and pharmacovigilance, Dr. Biffingnandi is an Advisory Board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group, a past president and now fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA), an overseas fellow of the Royal Society of Medicine and a renowned physician with PhDs in endocrinology and pharmacology. During his career, he has held CEO positions with major European pharmaceutical organisations, lectured on regulatory affairs at international symposia and published extensively on European regulatory affairs.


The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance.

For applications made under Article 10a, the applicant should justify the eligibility of the drug substance to be of well-established use (WEU). Under the European regulatory framework, a bibliographic application is admissible if the applicant can demonstrate that the API of the medicinal product was in well-established medicinal use within the EU for at least 10 years, with recognised efficacy and an acceptable level of safety. In that event, the pre-clinical and clinical-trial data normally required for an application may be replaced by appropriate scientific literature. If the dossier includes both published and own data, the submission would be considered a mixed marketing authorisation application and should be made under Article 8.3 of Directive 2001/83/EC.

All the above specifically excluded any study performed by the applicant, by definition, when the proposed product claimed for the same pharmaceutical form, strength(s) and indications. Chapter 1 of Volume 2A of the Notice to Applicants, on the contrary, placed a particular emphasis on the literature search strategy and on the definition of published literature.

However, recently, the attitude of the competent authorities has changed and now it is not uncommon to receive requests to bridge the literature data, which can or cannot have been obtained with the European reference product, with the proposed formulation. This implies some in vitro and/or in vivo data very similar if not identical to a bioequivalence study, i.e. an application according to Article 10(1), thus undermining the basis of the WEU.

Since this attitude from regulators now seems consolidated, the question arises: is it not the right time to re-define the basic concept of the WEU legal basis or, maybe, to cancel this option from the regulatory scene?


Dr. Paolo Biffignandi, paolo@elc-group.com.

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November 26, 2013

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