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Canada to potentially join parallel Scientific Advice with EMA and FDA for Complex Generics


Three years ago The FDA and the European Medicines Agency (EMA) have initiated a pilot program aimed at offering parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for FDA's complex generic drug products and marketing authorization applications (MAAs) for EMA's hybrid products.


Complex Generics/Hybrid Medicines


Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic.1


Hybrid medicines are medicines whose authorisation depends partly on the results of tests on the reference medicine and partly on new data from clinical trials.

Complex generic drugs present substantial market potential with the possibility of increased profit margins, yet manufacturers may face difficulties in their development due to limited expertise, methodologies, or supportive evidence.


The Pilot Program


The pilot program enables applicants seeking approval from both the FDA and EMA for complex generic drugs/hybrid products to request joint meetings with both agencies for discussions on development-related queries. Its aim is to facilitate simultaneous exchange of scientific perspectives between FDA and EMA assessors, aiding applicants in navigating the challenges associated with traditional bioequivalence methods and gaining insights from both agencies' recommendations.


After a PSA meeting, applicants should gain a clearer insight into the regulatory requirements of the agencies, receive scientific recommendations, and identify potential areas of divergence between them.

Two applicants have completed PSA meetings to date. Applicants have recommended procedural clarifications, clearer timelines and expectations, as well as best practices for meeting preparation. FDA and EMA plan to implement these recommendations to enhance the PSA process.


Potential applicants' concerns include:

  • Hesitation to join the PSA pilot program due to misperceptions about conflicting advice from both agencies potentially requiring additional testing.

  • Concerns about the perceived lack of binding or enforceable commitments from the agencies, which could limit the value and impact of the PSA advice.

  • Apprehension about sharing confidential information, potentially compromising competitive advantages.


Nevertheless, the concerns raised have not been supported by the experiences of pilot applicants, suggesting they may be unfounded. Safeguards, such as confidentiality agreements and redaction of sensitive data from public documents, are in place to protect applicants' confidential or proprietary information.

A recent webinar hosted by the FDA, titled "Expanding Generic Drug Access Through International Engagements," delved into the cooperation among international regulatory agencies. During the event, preliminary discussions centered on the potential inclusion of Health Canada in the PSA, a move that would further bolster the initiative. Such collaboration holds promise for enhancing regulatory harmonization and facilitating access to generic drugs on a global scale.


Our Managing Director Jasmina Savic commented "The potential inclusion of Health Canada in the PSA initiative marks a significant step towards fostering regulatory harmonization and expanding access to generic drugs worldwide. Collaborative efforts like these are essential in advancing public health agendas and facilitating innovation in the pharmaceutical industry. With our extensive experience in PSA, Phortas is well-positioned to contribute to the success of such initiatives."

Engaging with regulatory agencies early can improve the scientific quality and validity of a generic drug applicant's development plan. This proactive approach also helps mitigate the risk of encountering unexpected regulatory hurdles or surprises at later stages.


In this regard, Phortas can serve as a valuable partner, offering expertise and support throughout the process. For further inquiries or assistance, please contact us at info@phortas.com


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Disclaimer:

The views expressed in this article/presentation are the author's own and do not necessarily reflect those of Phortas GmbH. Phortas encourages readers to explore available information on the discussed topics and to rely on their own knowledge and expertise when making decisions

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