What is the BEST source for determining the format of a MAA intended for submission to a health authority?

Determining the format of a Marketing Authorization Application (MAA) for submission to a health authority is critical for ensuring compliance and facilitating the review process. Local health authority guidelines are the best source for this purpose because they provide specific requirements and expectations that must be met when submitting an application. These guidelines are tailored to the regulatory framework and procedures followed by the specific health authority in question, ensuring that the MAA aligns with their established standards for documentation, data presentation, and overall submission structure.

While consultants' recommendations, industry standards documentation, and international submission manuals can provide valuable insights and general best practices, they may not fully encompass the unique requirements mandated by the local health authority. Each authority may have distinct preferences or regulations that must be adhered to for a successful submission. Therefore, consulting the local health authority guidelines is essential for accurate and effective MAA preparation.