Association of South East Asian Nations CTD( ACTD)- A overview

Introduction:

 The Association of Southeast Asian Nations (more commonly known as ASEAN) is a political and economic organization aimed primarily at promoting economic growth and regional stability among its members. Asia’s regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each Asian country has its own set of regulations and customary manner of conducting business.

The following show the various Regulatory Authorities in each countries responsible for registration of medicines:-

COUNTRY	REGULATORY AGENCY
INDONESIA	NATIONAL AGENCY OF DRUG AND FOOD CONTROL
MALAYSIA	DRUG CONTROL AUTHORITY, NCE UNIT
PHILIPPINES	DEPARTMENT OF HEALTH
THAILAND	THAI FDA CONTROL DIVISION
SINGAPORE	HEALTH SCIENCES AUTHORITY
BRUNEI	MINISTRY OF HEALTH
VIETNAM	DRUG ADMINISTRATION OF VIETNAM
MYANMAR	FOOD AND DRUG ADMINISTRATION
CAMBODIA	DEPARTMENT OF FOOD DRUG AND COSMETICS
LAOS	MINISTRY OF HEALTH FOOD AND DRUG DEPARTMENT

Overview:

• ACTD Format, ASEAN Common Technical Dossier (ACTD) provides a common format for the preparation of well-structured Common Technical Dossier for submission to ASEAN regulatory authorities for registration of pharmaceuticals for human use.
• The guideline facilitates an efficient format for compiling the acquired data. Applicants can modify to provide to the best possible presentation of technical information for easy understanding and evaluation of the results.
• The ACTR is as set of written material intended to guide applicants to prepare an application in a way that is consistent with the expectations of all ASEAN Drug Regulatory Authorities.

                                           

Triangle view of ACTD

Advantages:-

• This guideline describes a format that will significantly reduce the time and resources needed to   compile application for registration.
• In the future, will ease the preparation of electronic documented submissions.
• The advantage of the ACTD is that one dossier can be used for the whole region rather than generating different registration dossiers.
• Facilitates the regulatory review in an efficient manner.

Submission:-

• The Pharmaceutical Regulatory Information System (PRISM) platform of HSA Singapore could be used for submitting an electronic copy of the complete CTD dossier.
• The complete dossier must be submitted in electronic format and as a colored scanned copy. Original hard copy not required.
• Module 1 /part 1 has to be submitted in soft-copy in prism. While modules 2 to 5 or parts 1 to 4 can be through PRISM or on CD OR DVD.
• In Malaysia, online web-based submission- QUEST 3 system/platform could be used.
• The requirement for paper-based submission remains for Vietnam, Indonesia, and Philippines.
• 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.

Conditions:-

Throughout the ACTD,

1. The display of information should be unambiguous and transparent.
2. Text and tables should be prepared using margins that allow the document to be printed on either A4 or 8.5 x 11 inches paper.
3. Font and size (Times New Roman, 12-point font)
4. Every page should be numbered, with the first page of each part designated as page 1.
5. Acronyms and abbreviations should be defined the first time they are used in each part. 
6. References should be cited

Dossier Approval Timelines:-

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

 Cambodia: 3 months

 Malaysia/Laos: 6 months

 Singapore: 9 months

 Philippines/Indonesia: 12 months.