What is the best source for determining the format of a Market Authorization Application (MAA) intended for submission?

What is the best source for determining the format of a Market Authorization Application (MAA) intended for submission?

• A. GMP
• B. Local health authority guidelines
• C. ICH
• D. WHO

Answer: (B)

The best source for determining the format of a Market Authorization Application (MAA) intended for submission is the guidelines provided by the local health authority. Each country or region's health authority has specific requirements and standards for the format and content of MAAs, as these can vary considerably based on local regulations and policies. Local health authority guidelines will provide comprehensive details on the structure, required documents, and any specific formatting instructions that need to be adhered to when submitting an MAA. Therefore, consulting these guidelines ensures that a submission aligns perfectly with the expectations and requirements of the reviewing body. While the other options may provide valuable information relevant to regulatory affairs, they do not specifically address the format and submission requirements of MAAs as consistently as the local health authority guidelines. Good Manufacturing Practices (GMP) pertain more to the production and quality systems of pharmaceuticals, the International Council for Harmonisation (ICH) offers broad guidelines that may apply internationally but might not cover local specifics, and the World Health Organization (WHO) sets international standards but does not replace local regulations.

The best source for determining the format of a Market Authorization Application (MAA) intended for submission is the guidelines provided by the local health authority. Each country or region's health authority has specific requirements and standards for the format and content of MAAs, as these can vary considerably based on local regulations and policies.

Local health authority guidelines will provide comprehensive details on the structure, required documents, and any specific formatting instructions that need to be adhered to when submitting an MAA. Therefore, consulting these guidelines ensures that a submission aligns perfectly with the expectations and requirements of the reviewing body.

While the other options may provide valuable information relevant to regulatory affairs, they do not specifically address the format and submission requirements of MAAs as consistently as the local health authority guidelines. Good Manufacturing Practices (GMP) pertain more to the production and quality systems of pharmaceuticals, the International Council for Harmonisation (ICH) offers broad guidelines that may apply internationally but might not cover local specifics, and the World Health Organization (WHO) sets international standards but does not replace local regulations.