EMA Explains How it Supports Article 58 Applications

Regulatory NewsRegulatory News | 07 February 2017 |  By 

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs).


First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration with the World Health Organization (WHO), on drugs to treat or prevent diseases that are global-health priorities that will only be marketed outside the EU.

To date, EMA has given positive opinions on seven products through Article 58, including antiretroviral and antimalarial drugs, as well as vaccines to protect against malaria, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b.

Last year, EMA reported on its first decade of experience with the Article 58 procedure, noting that the success of products assessed via the procedure has been limited.

"These seven products have experienced mixed commercial success in the LMICs' post-opinion," the report said. "While over 60% of these products have been hampered by poor [national regulatory authority] NRA recognition of Article 58 opinions, most of the products with positive opinion from Article 58 have suffered from poor commercial viability, unrelated to the regulatory pathway."

Article 58: Support

Now, in an effort to increase industry's utilization of Article 58, EMA is clarifying the avenues for support companies can access through the procedure.

First, EMA calls on drugmakers to seek out scientific advice during the development phase. "This procedure offers a platform to seek EMA's views of scientific questions concerning quality, non-clinical and clinical aspects in the context of the intended markets outside the European Union," EMA writes.

This recommendation follows one of the takeaways from the agency's report last year, which said that drugmakers found EMA's scientific advice "extremely helpful in shaping their clinical plans."

The agency also notes that experts from WHO and national regulators may be brought into the scientific advice procedure.

EMA encourages drugmakers to request business pipeline meetings with the agency. During these meetings, EMA says drugmakers have the opportunity to discuss their pipelines with "a restricted group of senior agency staff" to identify areas where the company may need guidance down the road.

Additionally, EMA clarifies that Article 58 applications are also eligible for the agency's tools for speeding access to new treatments, including accelerated assessment, conditional scientific opinions, and scientific opinions under exceptional circumstances.



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