Regulatory Strategy for ASEAN
- Insights from local regulatory experts
- Understand local dossier requirements, pathways and timelines
- Avoid common regulatory pitfalls
- Officially certified according to ISO 9001 and ISO 21001
Serie (abgeschlossen)
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting. The webcast sessions will be recorded and will be available in the Learning Space for 90 days.
Booking details
Serie (abgeschlossen)
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting. The webcast sessions will be recorded and will be available in the Learning Space for 90 days.
This webcast series provides a practical overview of regulatory approval pathways, dossier requirements and market entry considerations for pharmaceutical products across key ASEAN markets. You will learn how to prioritise target countries, plan efficient submission strategies and address important local requirements, timelines and common pitfalls.
Your speakers
What to Expect
- Overview of key ASEAN markets: Singapore, Malaysia, Indonesia, Thailand, Vietnam, the Philippines, Cambodia, Myanmar, Laos and Brunei
- Strategic planning of market prioritisation, submission sequencing and dossier preparation
- Practical guidance on approval pathways, ACTD/CTD requirements, GMP, labelling and pharmacovigilance
- Key considerations for timelines, local representation, import licences, registration samples and common deficiencies
- Comparative assessment of regulatory complexity, market attractiveness and practical entry options
Who Should Attend
The webcast series is designed for professionals from regulatory affairs, international registration, market access, global launch planning and related functions in pharmaceutical companies who are involved in preparing, coordinating or managing submissions in Southeast Asia.
Prior knowledge of EU regulatory frameworks is recommended.
Objective of the Event
This webcast series provides a practical overview of regulatory approval pathways, dossier requirements and market entry considerations for pharmaceutical products across key ASEAN markets. Participants will learn how to prioritise target countries, plan efficient submission strategies and understand important local requirements.
Can't attend live? All webcasts are available on demand for 90 days in the password-protected customer portal.
Your Benefit
You will gain:
- a compact overview of the main pharmaceutical regulatory frameworks in ASEAN
- practical guidance for submission planning and market prioritisation
- insights into country-specific requirements, timelines and common pitfalls
Programme
Dates: 19 + 20 + 24 + 25 November 2026, 09:00 - 11:00
09:00 - 09:10
- Speaker introductions and learning objectives
09:10 - 09:55
- Overview of the ASEAN pharmaceutical markets
- How to prioritise markets and sequence submissions
- Strategic considerations for dossier planning and market entry
- Timeline planning and critical path considerations
- Selecting local partners and planning local market access
- ASEAN Joint Assessment Procedure: status and relevance
- Q&A
09:55 - 10:00
10:00 - 11:00
- Pathway selection: Full, Abridged and Verification Route
- Verification Route: requirements, process and timeline
- Dossier requirements: CTD format, local administrative documents and product information requirements
- GMP: PIC/S membership, EU GMP recognition and inspections
- Labelling requirements
- E-submission via PRISM, pharmacovigilance and variations
- Common pitfalls and rejection reasons
- Q&A
09:00 - 09:55
- Pathway selection: Full, Abbreviated and Verification
- Dossier requirements: ACTD format, local annexes and substance documentation requirements
- GMP: PIC/S membership, EU GMP recognition and audits
- Halal certification: relevance, JAKIM requirements and planning considerations
- Labelling in Bahasa Malaysia, pharmacovigilance and variations
- Timelines and common deficiencies
- Q&A
09:55 - 10:00
10:00 - 11:00
- Registration procedures and product categories
- Dossier requirements: ACTD plus local documents
- Local regulatory requirements for manufacture, import and market access
- GMP: PIC/S status, CPOB inspections and EU GMP recognition
- Stability studies in zone IVb and other product-specific expectations
- Document legalisation requirements and current practice
- Labelling, local representation, pharmacovigilance and variations
- Timelines and deficiency letters
- Q&A
09:00 - 09:10
- Speaker introductions and learning objectives
09:10 - 10:00
- Registration procedures and product classification
- Dossier requirements: ACTD format, local specifics
- GMP inspections and EU GMP recognition
- Stability studies in zone IVb and storage conditions
- Labelling (Thai), local representation,
- Pharmacovigilance, variations and timelines
- Registration Samples and requirements (Import License)
- Thailand as a strategic gateway for Cambodia, Myanmar and Laos
- Market access and registration considerations for Cambodia, Myanmar, Laos and Brunei
- Q&A
10:00 - 10:05
10:05 - 11:00
- Registration pathways for initial applications, renewals and product maintenance
- Regulatory strategy for managing changing local requirements in practice
- Dossier requirements: ACTD format and local specifics
- GMP: EU GMP vs. WHO GMP recognition, inspections
- Bioequivalence, labelling in Vietnamese
- Stability studies and storage conditions
- Local representation, pharmacovigilance and variations
- Registration samples and import licence requirements
- Timelines
- Q&A
09:00 - 09:55
- CPR process, dossier requirements and GMP considerations
- Reliance on reference agencies
- Labelling, pharmacovigilance and variations
- Stability studies and Storage Condition
- Registration Samples and requirements (Import License)
- Timelines
- Q&A
09:55 - 10:00
10:00 - 11:00
- Summary of key regulatory considerations across the featured markets
- Comparative assessment of timelines, complexity and market attractiveness
- Comparative assessment of market attractiveness and practical entry considerations
- Q&A
09:00 - 09:10
Welcome and Introduction
Welcome and Introduction
- Speaker introductions and learning objectives
09:10 - 09:55
Introduction to the ASEAN Markets and Regulatory Strategy
Introduction to the ASEAN Markets and Regulatory Strategy
- Overview of the ASEAN pharmaceutical markets
- How to prioritise markets and sequence submissions
- Strategic considerations for dossier planning and market entry
- Timeline planning and critical path considerations
- Selecting local partners and planning local market access
- ASEAN Joint Assessment Procedure: status and relevance
- Q&A
Short break
10:00 - 11:00
Singapore (HSA)
Singapore (HSA)
- Pathway selection: Full, Abridged and Verification Route
- Verification Route: requirements, process and timeline
- Dossier requirements: CTD format, local administrative documents and product information requirements
- GMP: PIC/S membership, EU GMP recognition and inspections
- Labelling requirements
- E-submission via PRISM, pharmacovigilance and variations
- Common pitfalls and rejection reasons
- Q&A
09:00 - 09:55
Malaysia (NPRA)
Malaysia (NPRA)
- Pathway selection: Full, Abbreviated and Verification
- Dossier requirements: ACTD format, local annexes and substance documentation requirements
- GMP: PIC/S membership, EU GMP recognition and audits
- Halal certification: relevance, JAKIM requirements and planning considerations
- Labelling in Bahasa Malaysia, pharmacovigilance and variations
- Timelines and common deficiencies
- Q&A
Short break
10:00 - 11:00
Indonesia (BPOM)
Indonesia (BPOM)
- Registration procedures and product categories
- Dossier requirements: ACTD plus local documents
- Local regulatory requirements for manufacture, import and market access
- GMP: PIC/S status, CPOB inspections and EU GMP recognition
- Stability studies in zone IVb and other product-specific expectations
- Document legalisation requirements and current practice
- Labelling, local representation, pharmacovigilance and variations
- Timelines and deficiency letters
- Q&A
09:00 - 09:10
Welcome and Introduction
Welcome and Introduction
- Speaker introductions and learning objectives
09:10 - 10:00
Thailand (Thai FDA) and Selected Emerging ASEAN Markets
Thailand (Thai FDA) and Selected Emerging ASEAN Markets
- Registration procedures and product classification
- Dossier requirements: ACTD format, local specifics
- GMP inspections and EU GMP recognition
- Stability studies in zone IVb and storage conditions
- Labelling (Thai), local representation,
- Pharmacovigilance, variations and timelines
- Registration Samples and requirements (Import License)
- Thailand as a strategic gateway for Cambodia, Myanmar and Laos
- Market access and registration considerations for Cambodia, Myanmar, Laos and Brunei
- Q&A
Short break
10:05 - 11:00
Vietnam (DAV)
Vietnam (DAV)
- Registration pathways for initial applications, renewals and product maintenance
- Regulatory strategy for managing changing local requirements in practice
- Dossier requirements: ACTD format and local specifics
- GMP: EU GMP vs. WHO GMP recognition, inspections
- Bioequivalence, labelling in Vietnamese
- Stability studies and storage conditions
- Local representation, pharmacovigilance and variations
- Registration samples and import licence requirements
- Timelines
- Q&A
09:00 - 09:55
Philippines (FDA Philippines)
Philippines (FDA Philippines)
- CPR process, dossier requirements and GMP considerations
- Reliance on reference agencies
- Labelling, pharmacovigilance and variations
- Stability studies and Storage Condition
- Registration Samples and requirements (Import License)
- Timelines
- Q&A
Short break
10:00 - 11:00
ASEAN Market Comparison and Final Discussion
ASEAN Market Comparison and Final Discussion
- Summary of key regulatory considerations across the featured markets
- Comparative assessment of timelines, complexity and market attractiveness
- Comparative assessment of market attractiveness and practical entry considerations
- Q&A
Downloads
Request the documents using our form.
List of Abbreviations: Drug Regulatory Affairs / CMC
Weitere Informationen
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de