Do dossier should always be prepared in CTD format?

No, a dossier does not always have to be prepared in the Common Technical Document (CTD) format, although this is the preferred format for many regulatory authorities, especially in regions like the United States, Europe, Japan, and other countries following the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Here’s when CTD is required and alternatives to consider:

When CTD Format is Required?

The CTD format is widely used because it standardizes dossier preparation, making it easier for regulators to review and for companies to streamline submissions across multiple regions. Regulatory authorities requiring CTD include:

• FDA (USA)
• EMA (European Union)
• PMDA (Japan)
• Many other countries in regions like Canada, Australia, and some parts of Asia and Latin America

In these regions, a CTD or electronic CTD (eCTD) format is mandatory for new drug applications, generic drug applications, biologics, and other major regulatory submissions.

When CTD Format is Not Required?

In some countries, especially those with unique or developing regulatory frameworks, the CTD format is not mandatory, and dossiers may follow different requirements. Examples include:

• Non-ICH Countries: Some countries, especially in parts of Africa, the Middle East, and Latin America, may not strictly require CTD and might have their own formats.
• Traditional Formats: Regulatory bodies in a few countries still accept traditional or country-specific dossier formats, which may not be organized into the five-module CTD structure.
• ASEAN Common Technical Dossier (ACTD): In Southeast Asia, the Association of Southeast Asian Nations (ASEAN) has a format called ACTD, which is similar to CTD but includes specific requirements tailored for ASEAN member countries.

Situations When a Non-CTD Format May Be Appropriate

• Legacy Products or Local Generics: Some regions accept simpler dossier formats for local generics or older products.
• Herbal Medicines and Dietary Supplements: Regulatory requirements for herbal and nutraceutical products vary, and some may not require CTD format.
• Initial Submissions in Emerging Markets: For smaller markets, certain regulatory agencies may not yet have the infrastructure to handle CTD or eCTD submissions.

Choosing the Right Format

If you’re preparing a dossier, it’s essential to:

• Check Local Regulatory Guidelines: Always refer to the target regulatory authority’s guidelines to confirm the preferred format.
• Consider Long-Term Use: If planning to submit to multiple countries over time, it may be beneficial to start with the CTD format for consistency.
• Seek Regulatory Consultation: Many authorities offer pre-submission meetings where you can confirm specific requirements for your dossier format.

Using the correct format from the start is important, as regulatory agencies may reject or delay submissions that do not align with their standards.