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The US FDA and the European Medicines Agency (EMA) announced on September 15 that they have launched a pilot program to provide applicants for simplified new drug applications (ANDA) and EMA hybrid product marketing authorization applications (MAA) for FDA’s complex generic drug products Parallel Scientific Advice (PSA)
.
The pilot project is an extension of the FDA and EMA’s existing PSA for new drugs and biological products
.
The pilot program allows potential applicants applying for ANDA to FDA and MAA to EMA to submit meeting requests with the two agencies to discuss specific issues related to the development of complex generic drugs/hybrid products
.
The goal of the PSA pilot program is to provide a mechanism for FDA and EMA reviewers to exchange views with applicants on scientific issues during the development phase of complex generic/hybrid products, which usually use traditional bioequivalence methods It is more challenging to develop
.
The successful cooperation between the FDA and EMA through the PSA pilot project can give applicants a deeper understanding of the regulatory decision-making basis of the two agencies, optimize the applicant's global product development plan, and help applicants avoid unnecessary research duplication or unnecessary diversity The testing methods are optimized to satisfy both regulatory agencies and can shorten the approval time
.
The industry can initiate the PSA process by sending a "Request for PSA" letter (letter of reason) to the FDA and EMA to request a PSA meeting for complex generic/hybrid products
.
A request for a meeting will be received before the FDA and EMA determine that the completed PSA meeting is sufficient to evaluate the pilot program
.
The FDA also announced the general principles of the pilot project agreed by EMA and FDA.
The general principles will make the process and objectives of the PSAA program more transparent and help answer questions about the program
.
The pilot will start on September 15, 2021.
The pilot PSA meeting process is divided into three stages: 1) The first stage, the applicant requests a meeting with EMA and FDA; 2) The second stage, the EMA and FDA evaluation meeting package, the agency Conduct a bilateral preparatory meeting, and then a trilateral meeting with the applicant; 3) In the third stage, EMA and FDA communicate written responses to the applicant
The FDA pointed out that if the opinions of the two agencies disagree, the applicant will clearly understand the reason for the disagreement
.
Applicants can use the PSA program to determine whether the research design can be accepted by the two regulatory agencies
.
