July 2021 

GENERAL PRINCIPLES 

EMA-FDA PARALLEL SCIENTIFIC ADVICE 

(HUMAN MEDICINAL PRODUCTS) 

The European Medicines Agency (EMA) and the U.S. Food and Drug 

Administration (FDA) of the U.S. Department of Health and Human Services have 

a program to provide parallel scientific advice (PSA) to sponsors. The goal of the 

PSA program is to provide a mechanism for EMA assessors and FDA reviewers to 

concurrently exchange with sponsors their views on scientific issues during the 

development phase of new medicinal products (i.e., new human drugs and 

biologics). Such interactions are expected to increase dialogue between the two 

agencies and sponsors from the beginning of the lifecycle of a new product, provide 

a deeper understanding of the bases of regulatory decisions, optimize product 

development, and avoid unnecessary testing replication or unnecessary diverse 

testing methodologies. The agencies conduct PSA procedures under the auspices 

of the confidentiality arrangement between the European Commission, the EMA, 

and FDA. 

EMA and FDA have agreed to the following principles regarding PSA procedures and 

meetings. Posting this “General Principles” statement on the websites of both agencies 

will make the PSA program procedures and goals more transparent and help answer many 

questions about the program. Each agency will post this statement on its website in 

accordance with its own procedures. 

1. PSA procedures are voluntary and usually occur at the request of the sponsor; in special 

circumstances, EMA or FDA may also initiate the PSA process in full cooperation with the 

sponsor. “Sponsor” refers to: (a) the “sponsor” of an Investigational New Drug 

Application in the United States, (b) the “applicant” that submits a New Drug Application 

or Biologics License Application in the United States, or (c) a potential marketing 

authorisation applicant under the marketing authorisation process in the European Union. 

2. PSA requests should focus primarily on specific questions or issues involving the 

development of a medicinal product for which the sponsor desires to have further 

scientific input from both EMA and FDA. 

3. The PSA procedures should focus on sharing information and perspectives. Achieving 

harmonization and increased convergence is a potential beneficial outcome of the PSA 

process. Following PSA meetings, sponsors should have a clearer understanding of the 

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agencies’ respective requirements and perspectives regarding the development program 

discussed, and if divergent, the reasons for the divergence. 

4. The best candidates for PSA include important medicinal products, especially those 

being developed for indications lacking development guidelines, or if guidelines do exist, 

those for which EMA’s and FDA’s guidelines differ significantly. In addition, 

biosimilars, products with significant clinical safety, animal toxicology, or unique 

manufacturing concerns that could impede further product development are appropriate 

PSA candidates. Previous PSAs have involved medicinal products for oncology, antiinfectives, rare diseases, the pediatric population, and cardiovascular disease, as well as 

post-licensure commitment clinical trials. 

5. The number of PSA procedures will be limited. A PSA procedure should be a single 

occurrence focused on the specific development issue raised. A PSA procedure accepted 

by both agencies should not be viewed to include a continuing series of PSA procedures on 

the same product. 

6. The sponsor participates in a joint PSA meeting with EMA and FDA during the PSA 

procedure. In addition, the two agencies will conduct a pre-sponsor meeting tele- or 

videoconference to further discuss the sponsor’s questions. The two agencies may 

conduct a post-sponsor tele- or videoconference if needed. On rare occasions staff from 

one agency may travel to the other agency for such PSA meetings. Such travel should 

be at the expense of the agency for which the traveler works. 

7. The sponsor should usually focus on specific issues or questions in the PSA request. PSA 

issues or questions might occur in the margins of a FDA-designated “milestone” in the product 

development lifecycle, such as the end of phase 2 trials. 

8. Sponsors wishing to nominate a product for PSA should address one single “Request for 

PSA” letter to both emainternational@ema.europa.eu at EMA and US-FDAEUR@fda.hhs.gov at FDA. In this letter, the sponsor should provide the following 

information: (1) the product in development, (2) why a discussion with the assessors 

(reviewers) of EMA and FDA would be beneficial to the product’s development, (3) 

specific questions requiring clarification, (4) the desired goals for the meeting, and (5) an 

explicit authorization for the agencies’ comprehensive exchange of all information 

relevant to the product, including trade secret information (as defined by U.S. statute). 

Pursuant to legally established authorities, both agencies will maintain the confidentiality 

of all such information. 

9. A PSA request does not guarantee the PSA procedure will be granted. For a variety 

of reasons, one or both agencies may decline to participate in such a procedure. If 

a sponsor’s request for PSA is not granted, the sponsor is free to pursue a scientific 

advice procedure with each agency individually, following each agency’s normal 

procedural rules. Alternatively, both agencies can engage in a “consultative 
advice”.1 In this case, a limited number of experts from either side will be invited 

to participate in the discussions of the other agency. 

10. If both agencies grant the PSA request, the sponsor will receive an electronic mail 

message (email) from each agency acknowledging such agreement and indicating the 

primary contact person at each agency. The PSA process generally corresponds to the 70 day 

timeline of the EMA Scientific Advice Working Party (SAWP) and the timeline for a Type B 

meeting at FDA. (The annual SAWP meeting schedule is also accessible via the SAWP web 

page.) As such, the presently established timelines for the two agencies to conduct 

scientific meetings are not greatly discordant. Given the nature of EMA work, the tele- or 

videoconference with the sponsor and both agencies will usually be scheduled around day 60, 

in the margins of the SAWP meeting. The designated primary contact for each agency 

will coordinate with the sponsor final meeting logistics, including timelines for 

submission of pre/meeting background information to both agencies. PSA meetings are 

not Prescription Drug User Fee Act (PDUFA) meetings and are not subject to the 

performance goals for scheduling and holding PDUFA meetings. 

11. After a PSA procedure, each agency will retain its individual regulatory decision-making 

authority regarding drug development issues and marketing applications. The advice of 

each agency may still differ after the joint discussion. Each agency will provide the 

sponsor its independent advice on the questions posed during the PSA process, according 

to usual procedures and timelines. Sponsors should neither expect to receive similar 

recommendations from the two agencies regarding drug development issues nor expect to 

receive similar agency decisions regarding marketing applications that have undergone 

PSA. However, both agencies will strive to provide PSA responses that are convergent. 

12. Both agencies remain committed to meeting domestic process and review goals and 

timeframes. The PSA procedure should not adversely impact either agency’s 

ability to meet its formal domestic performance expectations. Both agencies 

commit to be cognizant of the other’s formal domestic performance expectations 

1 The Consultative Advice procedure allows sponsors to request scientific advice from one regulatory agency and concurrently notify the other 

regulatory agency of the request. At the invitation of the first agency, the second will participate in the sponsor meetings or teleconferences as 

able. Unlike the parallel scientific advice process, the second agency will be expected to only engage on top level issues. The review and 

sponsor meeting will follow the timelines of the regulatory agency from whom the sponsor initially seeks scientific advice. Only the initially 

contacted regulatory agency will provide written scientific advice in accordance with standard agency meeting procedures. 

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and to exhibit as much flexibility as possible in scheduling PSA meetings to avoid 

adversely impacting either agency’s ability to meet its formal domestic performance 

expectations. 

13. Any fees applicable for scientific advice are unaffected by PSA status.