The Drug Regulatory Landscape in the ASEAN Region

By Abhishek Tongia

This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Asian Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling, and drug variation information.

Introduction

The Association of Southeast Asian Nations (ASEAN) has diverse regulatory requirements for registering drug products. For example, the regulatory process for obtaining Marketing Authorizations (MAs) for drugs in ASEAN region, despite regional harmonization efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or "show-stoppers" for product registration/launches. While International Council for Harmonization (ICH) and European Medicine Agency (EMA) guidelines are acceptable in most of the ASEAN countries, there remain country-specific requirements to be addressed for successful MA approval by Health Authorities (HA). Although the Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. However, compliance with local administrative data, legal data, country specific stability requirement and product labelling is to be ensured. As a result, strategic planning is necessary for successful and timely product approvals.

Due to high price competition in the developed markets and growth of the generic drug market, many pharmaceutical companies are focusing on markets in the ASEAN countries. Having early visibility and information about ASEAN country-specific requirements and HA expectations will help the pharmaceutical industry to improve MA application planning, optimize and manage internal expectations and - most importantly – allow faster patient access to therapies.

The ASEAN Region

The ASEAN region comprises 10 countries: Malaysia, Indonesia, Thailand, Philippines Singapore, Brunei, Vietnam, Laos, Cambodia, and Myanmar. All 10 countries are seeking economic development to improve competitiveness by eliminating trade barriers. To help accomplish that, many ASEAN regulatory guidelines are harmonized with ICH and EU guidelines. However, country-specific requirements persist, with data sharing, mutual acceptance and recognition of current Good Manufacturing Practices (cGMPs), facilitated by ASEAN member countries who become Pharmaceutical Inspection Co-operation Scheme (PIC/S) members.

ASEAN organization was established on 8 August 1967 in Bangkok, Thailand. Initial participation began with five countries - Malaysia, Indonesia, Thailand, Philippines, and Singapore. ASEAN was later expanded to include Brunei, Cambodia, Laos, Myanmar and Vietnam.¹ The first trade initiative by ASEAN was taken in 1992 with the establishment of ASEAN Free Trade Area (AFTA) to promote economic development and improve competitiveness through the elimination of trade barriers. This step was followed by second initiative in 1999 with the establishment of the Pharmaceutical Product Working Group (PPWG) with an objective to have regional guidelines along with synchronization with ICH guidelines.²

The ASEAN region has developed ASEAN Common Technical Requirements (ACTRs), which provide guidelines for compilation of drug dossier and is comparable to Notice to Applicants (NtA) Volume 2C Europe.

The following countries are leading ASEAN Common Technical Document (ACTD) and ASEAN Common Technical Requirements:³

Indonesia - Quality (Q)

Thailand – Efficacy (E)

Philippines - Safety (S)

Malaysia - Administrative data, product information and glossary

In ASEAN countries, generic drugs may be marketed after the patent for an innovator drug/original drug expires. A patent is granted for a period of 20 years and cannot be extended. In Malaysia, there is a clause for data exclusivity stating that the period of data exclusivity shall not be more than:

• five years for a new drug product containing a new chemical entity
• three years for a second indication of a registered drug product; the period of data exclusivity is for the data concerning the second indication only.

There is no additional data exclusivity provided for pediatric medicine.⁴

In the author's experience, the Philippines accepts data and patent protection measures from other countries. In Malaysia, Indonesia, Philippines and Singapore, it is important to submit information regarding the Active Pharmaceutical Ingredient (API) manufacturing site, finished product manufacturing site, batch size, packaging site (primary and secondary), batch control testing, and release site.

Only one primary and secondary packaging site, finished product manufacturing site can be submitted to health authorities (except in Singapore).^5-9

Unlike European Medicine Agency (EMA) requirements, the addition of a finished product manufacturing site requires new registration and a complete dossier.

To increase transparency with patients, information about registered medicine is available on the health authority website of the Philippines, Malaysia, Singapore.^10-12

The Pharmaceutical Inspection Co-operation Scheme

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) 1970. PIC/S refers to both the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme as they operate in parallel. It is a non-binding, informal, co-operative arrangement between regulatory authorities in the field of cGMP of medicinal product for human or veterinary use. PIC/S comprises 49 authorities and aims at harmonizing inspection and facilitating co-operation as well as networking between competent authorities. Indonesia, Malaysia, Thailand and Singapore are members of PIC/S. FDA Philippines is currently being assessed for inclusion in the list of accepted ASEAN inspection services.¹³

As PIC/S members, ASEAN countries benefit by avoiding duplication of cGMP inspections within the countries and facilitating quick trade for medicinal product across this region, leading to faster patient access to medicinal products.

Certificate of Pharmaceutical Product (CPPs)

For product registration, MA renewal, major and minor variation applications, CPPs from country of origin (finished product manufacturing site) is generally required in World Health Organization (WHO) format along with samples and labels. Export certificates could be used in place of a CPP to facilitate submission. However, for getting HA approval CPP is required. Indonesia, Thailand, Vietnam and Philippines require legalized CPPs. In addition, CPPs in Indonesia are required if pharmaceutical goods are exported to overseas countries. A product-specific CPP is issued for each country of import. A CPP states whether or not a product is already distributed and sold in Indonesia. Where a product is limited to exportation, a standard comment will be included in the CPP with a rationale. Validity of CPP ranges from one year (Thailand) to two years.¹⁴

In most of the ASEAN countries, CPPs from reference countries, such as the US, Europe, Australia, Switzerland, Canada and Japan are acceptable.

ACTD/CTD Acceptability

Module Two of CTD is not present in ACTD and its respective content is included in Part II - Quality, Part III - Non-Clinical and Part IV – Clinical.¹⁵ The National Agency of Drug and Food Control (NADFC) Indonesia, the Drug Administrative department of Vietnam (DAV), Health Science Authority (HSA) Singapore, Food and Drug Administration (FDA) Philippines, Malaysia and Thailand accept only ACTD for generic applications, whereas the CTD format is acceptable for innovator, biological and biotechnological products. The Pharmaceutical Regulatory Information System (PRISM) platform of HSA Singapore could be used for submitting an electronic copy of the complete CTD dossier. In Malaysia, online web-based submission via Biro Pengawalan Farmaseutikal Kebangsaan (BPFK- Malaysia, National Pharmaceutical Control Bureau) QUEST3 system/platform could be used.¹⁶

The requirement for paper-based submission remains for Vietnam, Indonesia, and Philippines. For Singapore and Malaysia, paper submission of Part 1 and quality documents referring to 3.P.5 respectively is currently in force.

To facilitate the review of the basic data, the display of information should be unambiguous and transparent. Text and tables should be prepared using margins allowing the document to be printed on either A4 or 8.5 x 11 paper. The left-hand margin should be sufficiently large so that information is not obscured by the method of binding. Font - Times New Roman, size - 12-point, for text and tables large enough to be easily legible, even after photocopying could be ensured. Every page should be numbered with the first page of each part designated as page 1.¹⁷

Pharmacopoeias Acceptability

During formulation/product development, it should be considered that APIs and excipients must comply with pharmacopoeia currently in force.

Singapore and Malaysia do not have local pharmacopoeia. However, Thailand, Indonesia, Vietnam, Philippines do have local pharmacopeia in place. Apart from local pharmacopoeias, international pharmacopoeias, such as United State Pharmacopoeia (USP)/National Formulary (NF), British Pharmacopoeia (BP), European Pharmacopoeia, and Japanese Pharmacopeia are widely accepted in ASEAN countries.¹⁸

Harmonization of Technical Guidelines

The ASEAN Pharmaceutical Product Working Group (PPWG) was established by the ASEAN Consultative Committee for Standards and Quality (ACCSQ) with the objective of harmonizing pharmaceutical regulations of ASEAN member countries.^19,20 ASEAN harmonized guidelines are presented in Table 1.

The PPWG's harmonization activities include:

• existing technical guidelines and requirements discussion
• the study of harmonized procedures and regulatory systems currently implemented in other regions relating to technical guidelines and regulatory requirements
• the harmonization of technical guidelines and regulatory requirements applicable to the ASEAN pharmaceutical industry
• the development of CTDs with a view of arriving at Mutual Recognition Arrangement (MRAs)

Table 1. ASEAN Guidelines Harmonization
ASEAN Guidelines	Leading Country	Harmonized with Guidelines	Status
Process Validation	Singapore	EU	Approved and Implemented
Analytical Validation	Thailand	ICH
Bioavailability/Bioequivalence and Variations	Malaysia	EU
Stability Studies	Indonesia	ICH Q1A (R2), Q1B, Q1C, Q1D, Q1E, Q1F), EMA Guideline, WHO Guideline
Safety Studies	Philippines	ICH S1A, S1B, S1C(R), S2A, S2B, S3A, S3B, S4, S5(R2), S6, S7A, M3), without modification	Adopted
Efficacy Studies	Thailand	ICH E1, E2A, E2C, E3, E4, E6, E7, E8, E9, E10, E11

Halal Compliance for Muslim Patient Populations

It is important for the pharmaceutical product to be halal-compliant. Halal compliance is required in Malaysia and Indonesia. Halal pharmaceuticals are required to adhere to the following aspects of Shariah law.^21,22

They must not contain any parts or products of animals that are non-halal or are not slaughtered accordingly.

• no presence of najs (blood, urine, feces)
• safe for human use: non-poisonous, non-intoxicating or non-hazardous to health according to prescribed dosage
• cannot be prepared, processed, or manufactured using equipment contaminated with najs
• no presence of any human parts or derivatives that are not halal
• During preparation, processing, handling, packaging, storage and distribution, they must be physically separated from any non-halal products and najs.

Halal pharmaceuticals are subject to normal pre-marketing and post-marketing controls set by the relevant national pharmaceutical regulatory agencies. Halal products require certification from Islamic competent authorities. The Lembaga Pengkajian Panjan Obat Obatan dan Kosmetika Majelis Ulama (LPPOM MUI) of Indonesia and Department of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia or JAKIM) are bodies involved in certification of halal. In other countries, halal certification may be obtained from different bodies with varying degrees of mutual recognition.^23,24

Stability

Emphasis should be given to stability studies as they form a key element for submission in the ASEAN region. ASEAN countries fall in climatic Zone IV b; therefore, the general stability condition corresponds to 30°C ± 2°C/75% RH ± 5% RH - hot and very humid.

The 30°C ± 2°C/75% RH ± 5% RH requirement is the long-term stability condition for products in primary containers semi-permeable to water vapor, whereas for products in primary containers impermeable to water vapor it is 30°C ± 2°C and RH is not specified.²⁵

If submitted data is based on conditions that are less stressful (e.g., 30°C ± 2°C/65% RH ± 5% RH, 25°C ± 2°C/60% RH ± 5% RH) than those required, the data should be accompanied by appropriate complementary data which will permit conduct of a proper scientific evaluation.²⁶ Factors to be taken into consideration will include:

• whether any instability is seen
• whether data also have been provided under accelerated conditions
• whether more protective packaging is provided/required - a suitable label recommendation such as "Store below 30°C and protect from moisture" also may be applied.

Singapore and Indonesia require site-specific stability data or stability studies referring to the site where the commercial batch is produced. Malaysia, Philippines and Vietnam are flexible and do not have requirements for site-specific stability data.²⁷

For most of the ASEAN countries, 12 months real-time stability data with time point (real time) 0,3,6,9,12,18,24,36…. months and annually throughout the proposed shelf life is required. Accelerated condition (40°C ± 2°C/75% RH ± 5% RH) stability data corresponding to time point 0,3,6 months is widely accepted in the ASEAN region. Vietnam has a typical requirement of real time stability data until proposed shelf life.²⁸

For conventional dosage forms (e.g., immediate release solid dosage forms, solutions) and when the drug substances are known to be stable, stability data on at least two pilot scale batches are acceptable.²⁹

However, in the case of critical dosage forms (e.g. prolonged release forms/modified release, sustained release) or when the drug substances are known to be unstable, stability data on three primary batches must be provided. Two of the three batches should be at least of a pilot scale, while the third batch may be smaller, if justified.³⁰

Photo stability testing should be conducted on at least one primary batch of the drug product if appropriate. ASEAN accepts the standard conditions for photo stability testing as described in ICH Q1B.

The recommended stability tests parameters for different dosages forms should be considered in line with ASEAN stability guidelines.³¹ Stability test parameters for different dosage forms are presented in Table 2.

Table 2. Stability Test Parameters for Different Dosage Forms
Testing Parameters	Dosage Forms
	Tablets	Capsules (Hard and Soft)	Emulsion	Oral Solution/Suspension	Powder for Reconstitution*	Suppositories
Appearance	Yes	Yes	Yes	Yes	Yes	Yes
Odor	Yes	Yes	Yes	Yes	Yes	Yes
Color	Yes	Yes	Yes	Yes	Yes	Yes
Assay	Yes	Yes	Yes	Yes	Yes	Yes
Degradation	Yes	Yes	Yes	Yes	Yes	Yes
Dissolution/ Disintegration	Yes	Yes				Yes
Moisture/Water Content	Yes	Yes			Yes
Microbial		Yes	Yes	Yes
Viscosity		Yes	Yes	Yes
pH		Yes	Yes	Yes
Leakage		Yes
Pellicle		Yes
Preservative Content			Yes	Yes
Mean Size			Yes	Yes
Globules Distribution			Yes
Particle Distribution				Yes
Redispersibility				Yes
Rheological				Yes
Reconstitution Time					Yes
Softening Range						Yes
Particle Size						Yes
*Reconstituted products (solutions and suspensions) should be evaluated as described in oral solutions and suspensions above, after preparation according to the recommended labeling, through the maximum intended use period.

Product Labelling

Minimum mandatory information that should be included in the finished product drug label for the ASEAN region is product name, generic name, dosage form, strength, package size/net content, name and strength of active ingredient, formulation details, manufacturing date, expiry date, manufacturer/dealer detail, Marketing Authorization (MA) holder information, MA license number, batch number, storage condition, shelf life, indication, posology, contraindication, precaution, special warning, mode of administration/ direction for use, alcohol content, animal origin, statement for physician and other country specific information.³² Product labels in English are acceptable only in Singapore. For Philippines, Indonesia and Thailand product labels must be accompanied with Filipino, Bahasa and Thai language respectively.

However, in Vietnam and Malaysia, a product label must be in Vietnamese and Malay.^33-35

In the ASEAN region, the requirement for reimbursement, braille, identification, serialization/traceability is not yet evolved.

Warnings and cautionary statements that would be required on the inner label, unit carton, primary/secondary pack are country-specific for pharmaceuticals, such as Hydroquinone (skin irritation), Benzyl alcohol (avoid in children under two years of age. Not to be used in neonates), Paracetamol (Do not take any other paracetamol containing medicines at the same time), St. John's Wort , Yellow Tartrazin, antibiotics, antihistamines, Sedative Hypnotics, Antiepileptic's, and Corticosteroids.^36-38

Apart from this, pictograms, such as the symbol "Rx" on the left top corner of product name for Vietnam, a red dot and cross for Indonesia, and a Hologram in Singapore, are typical requirements.^39-42

Post Approval Changes (Variations)

ASEAN variation guidelines are applicable to pharmaceutical products for human use only, excluding biologics.⁴³ Variation are classified in two broad categories – major and minor.

Major Variation (MaV) means having significant impact on the aspect of finished product quality, safety and efficacy.⁴⁴

The Minor Variation (MiV) category is sub-divided as below, depending upon the impact of change on finished product quality, safety and efficacy.⁴⁵

• Minor variation Notification (MiV - N)
• Minor Variation Prior Approval (MiV - PA)

Following the receipt of a valid application, the timeline for drug regulatory authorities to evaluate the variation application is country-specific.

This overall classification of variations in the ASEAN region is in sync to a large extent with the post-approval change classification of Europe and US. Table 3 reflects the top level of harmonization for ASEAN EU and US. Also, any variation not listed in ASEAN guidelines could be justified by appropriate reference ⁴⁶ to:

• European Medicines Agency (EMA) Classification Guidance on Minor Variations of Type IA, Minor Variations of Type IB and Major Variations of Type II
• Scale-Up Post-Approval Changes (SUPAC) for Immediate-Release (IR) and Modified Release (MR) solid oral dosage forms, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation
• World Health Organization (WHO) Guidance on Variations to a Prequalified Product dossier

In the author's experience, ASEAN variation classification is analogous to EU and US to a great extent.

Table 3. ASEAN Variation Classification in Sync with EU and US
Types of Variations	ASEAN Classification	EU Classification 1234 / 2001 EC	US Classification 21 CFR 10.90(b)(9)
Minor (Notification)	MiV – N	Type IA – Do and Tell	CBE – 0
Minor (Prior Approval)	MiV – PA	Type IB	CBE – 30
Major (Prior Approval)	MaV	Type II	Prior Approval Supplement (PAS)

Note: in Singapore, MaVs are further subdivided into MAV-1 and MAV-2 categories and have approval times of approximately 270 and 180 days, respectively.

Indonesia has a similar approval time of between 150–300 days depending on the complexity of the variation. The remaining member states have not issued clear guidance on the expected time taken for MaV approval.

Pharmacovigilance and Risk Management Plan (RMP)

In most ASEAN countries, there is no specific requirement for RMP. ICH guidelines currently in force are accepted. RMP for biosimilar is required in Thailand; however, in Singapore⁴⁷ for Major Variation (MaV) and new drug applications, RMP is preferred.

In Indonesia⁴⁸, Philippines⁴⁹ and Singapore, it is mandatory to appoint a Qualified Person (QP) responsible for product safety, such as Adverse Drug Reactions (ADRs). The QP must have residential status in Singapore and Indonesia; for Philippines, it is not mandatory to have a QP as a resident.

Dossier Approval Timelines

For generic drugs, the review/approval process is not harmonized in the ASEAN region. In the author's experience, some tentative timelines for approval for generics applications by different health authorities are as follows:

• Cambodia: three months
• Malaysia/Laos: six months
• Singapore: nine months
• Philippines/Indonesia: 12 months.

For other ASEAN health authorities, there is no explicitly defined timelines for dossier approval.

Conclusion

The ASEAN region is emerging in the pharmaceutical marketplace with several countries leading in quality, efficacy, safety, BE/BA, and variations. It is important for the region to have more ASEAN countries accredited to PIC/S for the implementation and maintenance of harmonized cGMP standards and quality systems. In the author's experience, it would be good to have common filing procedures with full mutual acceptability in the ASEAN region. This will ensure rapid patient access to drugs, such as seen in the EU with Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and Centralized Procedure (CP). Economic diversity, language, uneven distribution of wealth, intellectual property, and lack of harmonization of guidelines and their implementation, are some of the challenges currently creating hurdles for pharmaceutical companies looking to penetrate these regions more effectively.⁵⁰

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About the Author

Abhishek Tongia is director regulatory affairs for the Asia India Middle East Africa (AIMEA) region at Teva Pharmaceutical, Singapore. He has held various positions over the last 17 years in global regulatory affairs with GlaxoSmithKline, Novartis, Ranbaxy etc. He has an MSc (pharmaceutical chemistry) and MBA (marketing) from DAVV University, Indore India. He can be contacted at abhishektongia@hotmail.com.

Cite as: Tongia, A. "The Drug Regulatory Landscape in the ASEAN Region." Regulatory Focus. January 2018. Regulatory Affairs Professionals Society.