1. Gap Analysis:

Analyze gaps between factory conditions and target market requirements, and guide the factory to supplement tests/documents.

2. Technical Documentation Preparation:

Prepare registration documents according to target market requirements.

3. Feedback Handling:

Address deficiencies based on official feedback.

4. Post-Marketing Management:

Execute registration variations and updates as needed.

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1. Definition and Background

Pharmaceutical registration regulations in Southeast Asian countries have complex backgrounds and environments. Due to differences in political, economic, and cultural conditions among countries, requirements and procedures for drug registration vary. However, countries are striving to improve technical standards and regulatory oversight to ensure drug safety and quality. Governments are actively promoting innovation in drug R&D and manufacturing to meet the region's growing pharmaceutical demands. General technical registration requirements are tailored to national conditions, ensuring drug safety and quality while fostering innovation and development in the local pharmaceutical industry.

2. Applicable Scope

·Drug Types: Chemical drugs, etc.

·Application Categories: New registration, renewal, variations (e.g., process changes).

3. Basic Requirements

·Target market's GMP and Guidelines

·ACTD/CTD documentation (varies by target market)

4. Registration Process

The process generally includes five steps:

Pre-submission → Submission → Screening → Technical evaluation → Decision

5. Regulatory Basis

·International Standards: WHO GMP, ICH Guidelines

·Target Market Guidelines, e.g.:

Philippines FDA, Thailand FDA, Vietnam DAV, Malaysia NPRA, Indonesia BPOM, Singapore HSA