Marketing Authorization and Regulatory Compliance in South-East Asian Pharmaceutical Markets

Marketing Authorization and Regulatory Compliance in South-East Asian Pharmaceutical Markets

• 1.
  SOUTH-EAST ASIAN MARKETS MarketingAuthorization and Post-Approval Requirements in Vietnam, Malaysia and the Philippines UNIT 5 SAROJINI NAIDU VANITA PHARMACY MAHA VIDYALAYA (CO – ED) (Sponsored By The Exhibition Society) (UGC AUTONOMOUS INSTITUTION) Affiliated To Osmania University Approved By PCI, NBAAccredited, Accredited A+ Grade By NAAC Presented by: Ms. Surampally Srilakshmi M.Pharmacy II sem Department of Regulatory Affairs 1704-25-867-012 Regulatory Aspects Of Drugs & Cosmetics
• 2.
  Contents Introduction Regulatory framework ACTD Structure Vietnam:Regulatory authority, Marketing authorization and post approval changes Malaysia: Regulatory authority, Marketing authorization and post approval changes Phillipines: Regulatory authority, Marketing authorization and post approval changes Comparision Conclusion References
• 3.
  Introduction • South-East Asiarepresents an important and rapidly developing pharmaceutical market. • Pharmaceutical products must obtain marketing authorization before being legally marketed. • Regulatory requirements differ among ASEAN countries despite ongoing harmonization efforts. • After approval, the Marketing Authorization Holder/Product Registration Holder must maintain compliance throughout the product life cycle. • Major post-approval activities include: • Variations • Renewal • Pharmacovigilance • Safety reporting • Product recalls • Labeling updates • Post-marketing surveillance
• 4.
  ASEAN Pharmaceutical Regulatory Framework ASEAN Harmonization • TheAssociation of Southeast Asian Nations promotes regulatory harmonization through: • ASEAN Common Technical Dossier (ACTD) • ASEAN Common Technical Requirements (ACTR) • ASEAN principles for pharmaceutical product variations • Harmonization of technical requirements among member states Importance • Reduces duplication of regulatory work. • Facilitates regional product registration. • Provides a common format for quality, safety and efficacy data. • However, each country retains its own national administrative and regulatory requirements.
• 5.
  ACTD Structure •ASEAN CommonTechnical Dossier (ACTD) •The ACTD is generally organized into four parts: •Difference from ICH CTD • ICH CTD contains Modules 1–5. • ACTD follows a four-part structure. • ACTD is widely used as a harmonized dossier format within ASEAN, although national requirements may differ. ACTD Part Content Part I Administrative data and product information Part II Quality documentation Part III Non-clinical documentation Part IV Clinical documentation
• 6.
  Vietnam: Regulatory Authority Regulatory Authority • Ministryof Health (MOH), Vietnam • The principal pharmaceutical regulatory body is the: Drug Administration of Vietnam (DAV) • Drug Administration of Vietnam – official portal Major Responsibilities • Evaluation of drug registration applications. • Granting of marketing authorization. • Renewal of marketing authorization. • Approval of changes and supplements. • Pharmacovigilance and safety monitoring. • Post-marketing quality surveillance. • Regulatory oversight of pharmaceutical products. • Vietnam's marketing authorization framework has recently been updated through national legislation and implementing regulations, including Circular 12/2025/TT-BYT
• 7.
  Vietnam: Marketing Authorization Process Applicant / Manufacturer ⬇ Preparationof Registration Dossier ⬇ Submission to Drug Administration of Vietnam ⬇ Administrative and Technical Review ⬇ Evaluation of Quality, Safety and Efficacy ⬇ Regulatory Decision ⬇ Grant of Marketing Authorization Key documentation can include administrative and legal documents, quality data, and—depending on the product category—supporting safety and efficacy information. Vietnam also applies ASEAN technical dossier principles in pharmaceutical regulation.
• 8.
  Vietnam: Major Marketing Authorization Requirements Key Requirements • Dependingon the product and regulatory pathway, the application may require: • Application form. • Administrative and legal documents. • Manufacturer information. • Product information and labeling. • Certificate of Pharmaceutical Product or relevant legal documentation for imported products. • Quality documentation. • Stability data. • Safety and efficacy documentation where applicable. • Technical documentation supporting the proposed product. • Appropriate GMP compliance evidence. Regulatory Evaluation • The authority evaluates the product based on: • Quality + Safety + Efficacy • The Vietnamese regulatory framework provides for defined procedures for granting, renewing and changing marketing authorization.
• 9.
  Vietnam: Validity and Renewal Validity ofMarketing Authorization • Generally: • 5 years for a marketing authorization, subject to applicable exceptions. • 3 years for products requiring continued monitoring of safety and efficacy, including certain new products. Renewal documentation may include: • Renewal application. • Valid pharmaceutical product documentation for imported products, where applicable. • Safety and efficacy report from the marketing period. • Vietnam's current framework also specifies that an application for renewal must be submitted before expiry under the applicable procedure.
• 10.
  Vietnam: Post- Approval Requirements • Changesafter approval may require submission to the regulatory authority. Examples include: • Change in manufacturer. • Manufacturing-site changes. • Changes in manufacturing process. • Changes in specifications. • Changes in packaging. • Labeling changes. • Changes in administrative information. • Changes that may affect quality, safety or efficacy. • The dossier for a change generally includes: • Application for change/supplementation. • Technical documentation supporting the proposed change. • Vietnam also provides shorter regulatory handling for certain changes that do not affect product quality, safety or efficacy.
• 11.
  Malaysia: Regulatory Authority •National Pharmaceutical Regulatory Agency (NPRA) • The NPRA operates under Malaysia's Ministry of Health and supports regulatory control of pharmaceutical products. • National Pharmaceutical Regulatory Agency (NPRA) Key Functions • Product registration. • Evaluation of pharmaceutical products. • Regulatory review of variations. • Pharmacovigilance. • Post-marketing surveillance. • Product quality monitoring. • Product recalls and regulatory enforcement.
• 12.
  Malaysia: Marketing Authorization Theapplicant or Product Registration Holder (PRH) is responsible for obtaining product registration. Product Classification ⬇ Preparation of Regulatory Dossier ⬇ Electronic Submission ⬇ Screening and Evaluation ⬇ Quality, Safety and Efficacy Assessment ⬇ Regulatory Decision ⬇ Product Registration • Malaysia uses the Drug Registration Guidance Document (DRGD) as a major regulatory guidance resource for pharmaceutical registration and product lifecycle requirements.
• 13.
  Malaysia: Dossier Requirements Major Documentation • Dependingon product category, the dossier may contain: • Administrative information. • Product particulars. • Manufacturer details. • GMP-related documentation. • Quality data. • Stability data. • Non-clinical data. • Clinical data. • Product labeling. • Package insert. • Technical Dossier • The application follows the applicable Malaysian requirements and harmonized technical principles, with product-specific requirements defined in NPRA guidance.
• 14.
  Malaysia: Post-Approval Variations •VariationCategories •Malaysia classifies pharmaceutical variations into: •Important Requirement •Except for eligible notification-type changes, changes to registered product particulars generally require appropriate regulatory handling before implementation. •Failure to obtain required approval can result in regulatory action, including possible review of suspension or cancellation of registration. Category Meaning MaV Major Variation MiV-PA Minor Variation – Prior Approval MiV-N Minor Variation – Notification
• 15.
  Malaysia: Pharmacovigilance and Post-Marketing Surveillance Responsibilities ofthe PRH • The Product Registration Holder must: • Maintain a pharmacovigilance system. • Monitor adverse drug reactions. • Report relevant safety issues. • Monitor local and international safety information. • Take appropriate safety actions. • Comply with NPRA safety directives. Post-Marketing Activities • Include: • ADR reporting. • Safety updates. • Product complaints. • Product recalls. • Post-market surveillance. • The NPRA explicitly places responsibility on PRHs to maintain pharmacovigilance systems and monitor/report relevant safety issues.
• 16.
  Philippines: Regulatory Authority • Foodand Drug Administration (FDA), Philippines • The Philippine FDA regulates pharmaceutical products before and after marketing authorization. • Philippine Food and Drug Administration Key Functions • Product registration. • Evaluation of quality, safety and efficacy. • Issuance of Certificates of Product Registration. • Approval of post-approval changes. • Pharmacovigilance. • Post-market surveillance. • Product recalls and regulatory enforcement.
• 17.
  Philippines: Marketing Authorization Product Classification &Pathway Selection ↓ Dossier Preparation ↓ Submission to Philippine FDA / CDRR ↓ Pre-assessment & Completeness Check ↓ Payment of Regulatory Fees ↓ Technical Evaluation (Quality + Safety + Efficacy) ↓ Clarification / Additional Data, if required ↓ FDA Regulatory Decision ↓ Certificate of Product Registration (CPR) Marketing Authorization Granted ↓ Post-Marketing Surveillance + Pharmacovigilance + Variations + Renewal
• 18.
  Philippines: Major Dossier Requirements Typical Requirements •Application documents. • Administrative and legal documents. • Authorization/licensing documents. • Product information. • Quality documentation. • Stability data. • Safety and efficacy documentation, as applicable. • Labeling and package insert. • ACTD or ICH CTD documentation where required. • For certain facilitated registration pathways, the Philippine FDA specifically requires a complete ICH CTD or ACTD dataset along with other pathway-specific documents.
• 19.
  Philippines: Post-Approval Changes Post-approvalchanges may involve: • Administrative changes. • Quality changes. • Clinical/non-clinical changes. • Manufacturing-site changes. • Labeling changes. • Product information updates. Major Categories •Under ASEAN-aligned variation concepts: •The Philippine FDA's existing framework incorporates the ASEAN Variation Guideline and country-specific requirements for PACs. Category Requirement MaV Major Variation MiV-PA Minor Variation – Prior Approval MiV-N Minor Variation – Notification
• 20.
  Comparison of thethree countries
• 21.
  Post-Approval Lifecycle Management Marketing Authorization ⬇ Commercial Distribution ⬇ Pharmacovigilance ⬇ Post-MarketingSurveillance ⬇ Product Complaints ⬇ Variations / Changes ⬇ Safety Updates ⬇ Renewal ⬇ Continued Market Authorization
• 22.
  Conclusion • Vietnam, Malaysiaand the Philippines are important pharmaceutical markets in South-East Asia. • Marketing authorization requires comprehensive regulatory evaluation before a product enters the market. • ASEAN harmonization through the ACTD and related regulatory principles supports greater regional consistency. • However, country-specific administrative requirements remain important. • Post-approval compliance is essential throughout the product life cycle. • Variations, renewals, pharmacovigilance and post-marketing surveillance are critical responsibilities of the authorization holder.
• 23.
  References Vietnam • Ministry ofHealth / Drug Administration of Vietnam • DAV regulatory and administrative services portal • Vietnam Ministry of Health legal framework on marketing authorization, renewal and changes. Malaysia • NPRA – Drug Registration Guidance Document and r elated guidance • NPRA Post-Marketing Activities • NPRA Pharmacovigilance Guidelines Philippines • Philippine FDA – Facilitated Registration Pathways • Philippine FDA – WHO Collaborative Procedure • Philippine FDA post-approval change framework