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                CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA)

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          Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug ProductsCDER Small Business & Industry Assistance (SBIA) Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
  
  	
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Dr. Sarah Ibrahim Head Photograph

Dr. Sarah Ibrahim, PhD, Associate Director of Stakeholder and Global Engagement
Office of Generic Drugs | CDER |

The generic drug pharmaceutical industry and the agencies that regulate them are increasingly seeking opportunities to proactively engage in the early stages of generic drug product development. The Parallel Scientific Advice (PSA) pilot program allows for applicants to engage in concurrent scientific conversation with both agencies, the FDA and the European Medicines Agency (EMA), on key issues during the development phase of complex generic drug products and hybrid products.

The EMA uses the term “hybrid medicines” for medicines whose authorization depends partly on the results of tests on the reference medicine and partly on new data, some of which can include what FDA defines as complex products. It allows prospective applicants of abbreviated new drug applications (or ANDAs) to FDA and marketing authorization applications (or MAAs) to EMA to submit a request for a meeting with both agencies to discuss specific questions regarding the development of complex generic drug or hybrid products. Through the PSA process, ANDA applicants can gain an understanding of both agencies’ recommendations.

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 (or reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic. Through the PSA process, applicants would gain an understanding of both agencies’ recommendations. We highly encourage applicants to participate.

The pilot PSA program is very beneficial to applicants. Successful collaboration between FDA and EMA via the PSA program increases dialogue between the two agencies and optimizes the applicant’s global product development program by enabling them to discuss specific questions regarding complex generic drug products and hybrid products. It further provides applicants with a deeper understanding of the basis for regulatory decisions from both agencies, helping applicants avoid redundant replication of work and unnecessary testing replication or unnecessary diverse testing methodologies. And this in turn can shorten the time to approval. Participation in the PSA program is voluntary and initiated by the applicant, but it’s been a challenge to garner interest among applicants.

The program is new, and we need to continue raising awareness to its existence and benefits to the generic drug development process. We evaluated the preliminary assessment of the PSA program to gain insight on how to advance participation and want to ensure applicants that the program has already begun implementation of these recommendations.

The PSA program focuses on sharing information and perspectives. 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 the advice from the two agencies is divergent, the applicant will have a clear understanding of the reasons for divergence.

Candidates for the PSA program may use the Program to determine whether a study design, or designs, might be acceptable to both regulatory agencies including comparative non-clinical and comparative clinical studies involving innovative bioequivalence study designs and the use of methodologies such as modeling and simulation.

Participation is not a complicated process. We encourage applicants to participate. Industry can request PSA meetings for complex generic drugs and hybrid products by sending a single “Request for PSA” justification letter to both EMA at emainternational@ema.europa.eu and FDA at preANDAHelp@fda.hhs.gov to initiate the PSA process. For each approved PSA request, the agencies will hold one trilateral meeting with the applicant focused on the specific development issues raised.

Meeting requests will be received until FDA and EMA determine the number of completed PSA meetings is sufficient to assess the pilot program. During and after conclusion of the pilot, each agency will evaluate the benefits and challenges of the program, including the resources required, and determine next steps.

This program is helpful for applicants and patients, and we encourage applicants to participate. Not only will participation increase dialogue among the two agencies and applicants from the beginning of the lifecycle of a complex generic drug product, but it will provide a deeper understanding of the basis of regulatory decisions, optimize product development, and avoid unnecessary replication of studies or unnecessary diverse testing methodologies.

Achieving harmonization and increased convergence are potential benefits of the PSA program, ultimately serving patients globally.

Resources

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products | FDA

                                                                                  Content current as of:
      07/11/2023
              
              
Regulated Product(s)
		 DrugsCDER Small Business & Industry Assistance (SBIA)

          
                        About CDER Small Business and Industry Assistance (SBIA)
          CDER SBIA Learn
          Search for Regulatory References | Drugs
          CDER SBIA YouTube Learning Library
 
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