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EMA/309801/2017April 2017GENERAL 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

How to fill out ema-fda parallel scientific advice

How to fill out ema-fda parallel scientific advice:

1. Start by thoroughly reviewing the guidelines provided by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) regarding parallel scientific advice. Familiarize yourself with the process, requirements, and timelines.
2. Determine if your company or organization is eligible for ema-fda parallel scientific advice. Typically, this type of advice is sought by pharmaceutical companies developing medicinal products for gaining regulatory approval in both the European Union and the United States.
3. Gather all the necessary documentation and information required for the parallel scientific advice request. This may include preclinical or clinical data, study protocols, trial designs, statistical analyses, safety and efficacy information, and any relevant regulatory or scientific questions.
4. Prepare a clear and concise cover letter outlining the purpose and objectives of seeking ema-fda parallel scientific advice. Include the specific questions or issues you would like addressed by both agencies.
5. Complete the ema-fda parallel scientific advice request form, ensuring all sections are accurately filled out. Provide detailed information about the product under development, including its intended use, active substances, formulation, and proposed indication.
6. Attach all supporting documents, ensuring they are well-organized, properly labeled, and easy to understand.
7. Submit the ema-fda parallel scientific advice request to both agencies within the appropriate deadlines specified in their guidelines. Follow the specific submission instructions provided by each agency, including any required forms, formats, or electronic submission platforms.

Who needs ema-fda parallel scientific advice:

1. Pharmaceutical companies developing medicinal products for gaining regulatory approval in both the European Union and the United States may need ema-fda parallel scientific advice.
2. Companies seeking to optimize the development and regulatory strategies of their products by obtaining simultaneous feedback and guidance from both regulatory agencies may also benefit from ema-fda parallel scientific advice.
3. Researchers, scientists, and regulatory professionals involved in the development of pharmaceuticals that require approval in both the EU and US can greatly benefit from ema-fda parallel scientific advice to ensure compliance with the requirements of both agencies and streamline the approval process.

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What is ema-fda parallel scientific advice?

EMA-FDA parallel scientific advice is a regulatory procedure that allows pharmaceutical companies to seek advice from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) simultaneously, with the aim of aligning regulatory requirements and improving the efficiency of drug development and approval processes in both regions.

Who is required to file ema-fda parallel scientific advice?

Pharmaceutical companies that are developing drugs intended for both the European Union (EU) and the United States (US) markets may seek to file for EMA-FDA parallel scientific advice.

How to fill out ema-fda parallel scientific advice?

To fill out EMA-FDA parallel scientific advice, pharmaceutical companies need to submit a request to both EMA and FDA, providing comprehensive information about their drug development program, including data on preclinical and clinical studies, regulatory strategy, and any specific questions or concerns they may have. The request should follow the specific guidelines and procedures outlined by both regulatory agencies.

What is the purpose of ema-fda parallel scientific advice?

The purpose of EMA-FDA parallel scientific advice is to enhance collaboration and harmonization between the regulatory agencies of the EU and the US, facilitate early communication between pharmaceutical companies and regulators, streamline drug development processes, and ultimately improve patient access to safe and effective medicines.

What information must be reported on ema-fda parallel scientific advice?

When seeking EMA-FDA parallel scientific advice, pharmaceutical companies must report comprehensive information about their drug development program, including preclinical and clinical data, study designs, regulatory strategies, endpoint selection, statistical analysis plans, safety evaluation, risk management plans, and any specific questions or concerns they may have.