April 17, 2025

Medical writing is a cornerstone of effective healthcare communication, translating scientific knowledge into clear, accurate, and accessible content. In Indonesia, the demand for skilled medical writers is growing in tandem with the expanding pharmaceutical, nutraceutical, and healthcare industries. Adhering to national and international regulatory standards, writers in this field must balance scientific accuracy with cultural and linguistic relevance.

Understanding Medical Writing in the Indonesian Context

Medical writing in Indonesia involves crafting content for diverse purposes:

  • Regulatory Documentation: Includes submissions to Indonesia’s National Agency of Drug and Food Control (BPOM), clinical trial documents, pharmacovigilance reports, and risk-based assessments under BPOM’s Online Single Submission (OSS) system.
  • Scientific Communication: Manuscripts, journals, and conference presentations targeting local and international audiences.
  • Educational Content: Patient leaflets, health articles, and continuing medical education (CME) materials adapted to Bahasa Indonesia and local dialects.

Indonesian medical writers must navigate both global best practices and local regulatory landscapes while addressing challenges such as evolving guidelines and stringent compliance requirements.

Key Medical Writing Guidelines in Indonesia

1. Language Precision and Cultural Relevance

  • Use simple, clear language when writing for the general public, ensuring readability and engagement.
  • Translate and localize content to Bahasa Indonesia when required while maintaining accuracy and cultural sensitivity.
  • Consider regional dialects or nuances when creating patient-facing materials.

2. Regulatory Compliance

  • Align documentation with BPOM regulations such as Risk-Based Approach OSS requirements.
  • Follow ASEAN Common Technical Dossier (ACTD) guidelines for pharmaceutical submissions.
  • Adhere to global standards like ICH (International Council for Harmonisation) and GCP (Good Clinical Practice) for clinical research documentation.

3. Scientific Integrity

  • Present all data accurately, backed by evidence from credible sources.
  • Avoid plagiarism by properly citing references and disclosing conflicts of interest in scientific or promotional materials.

4. Audience-Specific Communication

  • Tailor tone and depth based on whether you're writing for regulators, healthcare professionals, or patients.
    • For regulatory submissions: Prioritize precision, adherence to format, and compliance with BPOM’s guidelines.
    • For health education: Focus on simplicity, readability, and cultural relevance.

5. Formatting and Structure

  • Use proper formatting tools such as tables, bullet points, charts, and standardized headings for clarity.
  • Ensure version control and document traceability to facilitate audits or inspections.

Recent Regulatory Updates in Indonesia

Medical writers must stay updated on new regulations impacting healthcare communication. For instance:

  • Medical Device Regulations: The Ministry of Health introduced new requirements for medical device distributors effective January 2025.
  • BPOM’s RBA OSS System: This system streamlines submissions but requires meticulous documentation to meet risk-based assessment criteria.

How Maven Supports Medical Writing in Indonesia

Maven Regulatory Solutions brings international expertise combined with local adaptability to support Indonesian companies and researchers. Here’s how Maven stands out:

1. Multilingual and Multicultural Expertise

Maven’s team produces content in both English and Bahasa Indonesia, ensuring regulatory documents meet national standards while being accessible to local stakeholders.

2. Regulatory Navigation

With deep knowledge of BPOM regulations, ASEAN frameworks, and global standards like ICH/GCP:

  • Maven assists in preparing dossiers for pharmaceuticals, cosmetics, food supplements, chemicals, and medical devices.
  • The team guides companies through BPOM’s Risk-Based Approach OSS system to ensure seamless submissions.

3. Scientific and Clinical Accuracy

Maven writers combine scientific rigor with regulatory awareness to deliver high-quality outputs such as clinical study protocols, reports, summaries, hazard communication documents (SDS), and label assessments.

4. Lifecycle Document Management

From early-phase development to post-market reporting:

  • Maven supports the entire documentation lifecycle by providing updates, translations, compliance checks, claim validation services, and more.

5. Tailored Services Across Industries

Maven offers tailored solutions across industries:

  • Document review for pharmaceuticals.
  • Label assessment for food supplements.
  • Regulatory support for cosmetics under BPOM guidelines.

Conclusion

Medical writing in Indonesia is a dynamic, evolving field that requires a balance of local insight, scientific expertise, and regulatory awareness. By following best practices and leveraging the expertise of Maven Regulatory, companies can ensure their documentation is compliant, effective, and impactful whether for submission, education, or publication.