FDA, EMA launch complex generic, hybrid product advice pilot

Regulatory NewsRegulatory News
| 15 September 2021 | By Michael Mezher 

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on Wednesday launched a new pilot aimed at giving parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the EU.
FDA says the pilot is an expansion of the two agencies' existing parallel scientific advice programs for new drugs and biologics. The tenets for the pilot and details regarding the process and procedures are laid out in a joint general principles document released by both agencies.
"The goal of the PSA program is to provide a mechanism for EMA and FDA to concurrently consider and jointly exchange with applicants the agencies' views on scientific questions during the development phase of hybrid/complex generic products," the two agencies write, adding that they anticipate increased dialogue with applicants during the early stages of development.
"Successful collaboration may provide applicants with a deeper understanding of the basis of regulatory decisions, optimize product development, and avoid unnecessary replication of studies or unnecessary testing methodologies," the agencies write.
The agencies also explain that the voluntary program will only consider products that meet both the FDA's definition of complex generic and EMA's definition of a hybrid medicine as the regulatory definitions differ between the two jurisdictions.
Meeting requests for the pilot will be accepted beginning 15 September 2021 and will remain open until enough have been held for the agencies to assess the program.
The meeting process will consist of three stages, with applicants first requesting a meeting with both agencies. The agencies will then assess the meeting package and conduct a bilateral preparatory meeting before conducting a trilateral meeting involving the applicant. The trilateral meetings are expected to be one and a half hours but may be longer depending on the complexity of the issues to be discussed. After the trilateral meeting has been conducted, the agencies will send written communications to the applicant.
Meetings conducted under the pilot are covered under the existing confidentiality agreement between the US and EU regulators.
"Following a PSA meeting, an applicant will have a clearer understanding of the agencies' respective regulatory requirements and scientific recommendations regarding the development program discussed. If advice from the two agencies is divergent, the applicant will have a clear understanding of the reasons for the divergence," the agencies write.
Some examples of studies that may benefit from parallel scientific advice in the complex generic/hybrid product space include "comparative non-clinical and comparative clinical studies involving innovative bioequivalence study designs and the use of methodologies such as modeling and simulation."
FDA, General Principles


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