To many of the principals out there, ASEAN remains one of the biggest untapped market . But yet, there are many “mysteries” surrounding the ASEAN’s regulations. for filing of pharmaceutical products. Common questions encountered are like: What are the regulatory requirements? What are the obligations as a marketing authorization holder? What business model would be most appropriate to work with? As such, many principals fail to understand the needs and hence misunderstanding arises with local partners. Based on experience, the easiest to start with would be to work on the regulatory dossier at hand. Regulatory dossier is like the set of legal documents that you have to prepare in order for you to get the “VISA” =product licence into the country.
Let’s come down to the top 5 questions to check your dossier against before filing:
- Do you have a PIC/S GMP? PIC/S stands for pharmaceutical international cooperation scheme and is a “international standard” for the pharmaceutical industry to follow with regards to manufacturing operations. Many of the ASEAN countries health authority follows this standard for pharmaceutical products. Having a PIC/S GMP(Good Manufacturing Practice ) can save you plenty of time from on-site inspection , hefty costs as well as the long waiting time arranged finally for the site inspection. Use the below link to check out whether the GMP issued falls under PIC/S: https://www.picscheme.org/en/members
- Do you have Zone IVb stability studies? ASEAN climatic zone lies in hot and humid region hence it is important the products are able to maintain their quality and efficacy throughout the shelf life proposed . At minimum, there should be about 12 months of real time data[(30 30°C/75%Relative Humidity (RH)] and 6 months of accelerated data( [(40 30°C/75%Relative Humidity (RH)] ) for two batches for non-critical dosage forms ( Immediate Release Solid Oral Dosage Forms such as capsule and tablets) and 3 batches of the above data for critical dosage forms( injectables, oral-modified dosage forms, sterile preparations) .
- What is the reference product used in Bioequivalence (BE) study? *applicable especially for filing generics product* Health Authorities in ASEAN prefer that the bioequivalence studies are conducted using the registered source in their own country. If not, bridging studies are often required which includes but not limited to comparative dissolution studies.
- Is your dossier arranged in ASEAN Common Technical Dossier (ACTD) format? ACTD format comprises of 4 part namely Part I: Adminsitrative documents, Part II: Quality [Chemical Manufacturing Control(CMC) portion lies], Part III: Non-clinical, Part IV: Clinical documents. The structure remains essentially similar to that of the International Council of Harmonization Common Technical Document (ICH CTD) format which have 5 parts. Certain country such as Singapore can accept the original ICH CTD format for filing and hence arrangement of the dossier is not required.
- Labelling: are you ready to adapt to the specifics requested for labelling? Some specifics include but not limited to individual registration number, specific wording in country’s own native language to be printed on carton as well as the Summary of Product Characteristics (SPC)/ Patient Information Leaflet(PIL) in country’s own native language.
If you have checked more than 3 of the above(especially point 1,2 and 4) , you are about 80% ready to enter the market and cross the regulatory barrier. Hopefully this simple checklist can come into your mind when developing your business plan for the ASEAN market and raise some awareness for your meeting with your ASEAN partners.