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In the last two decades, Thailand, a country with a population of approx. 67 million has witnessed a commendable growth in healthcare sector. After Indonesia, Thailand has the largest drug market that is expected to get double by the year 2020. As per research reports, the Thai government spends 14% on healthcare, which is more than many European countries. This is why the Thai FDA is continuously attempting to regulate and monitor this industry in order to ensure that these medical products are safe to use for its people. Subsequent to which the agency has proposed guidelines for pharmaceutical companies to submit relevant and precise information about their products in a particular format that ensures drug safety.
The Thai Food and Drug Agency announced acceptance of Pilot eCTD from October 2014. The agency has scheduled acceptance of the eCTD submission from May 2015 and announced to make e-CTD submissions mandatory from 2017. As we are entering 2016, the eCTD format for New Chemical Entities (NCE) and New Molecular Entity (NME) will be made mandatory. Followed by announcement, a guidance draft for e-submissions was proposed by Thai FDA which has been designed in reference to the structure of Module 1 of European and Canadian guidelines for generating eCTDs. For Modules 2 to 5, Thai FDA has developed guidance based on International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), eCTD specifications v3.2.2. The reason behind referring to the guidance from other countries is to build a structure friendly to harmonization with other regions.
Dossier Filing Process
- Application Preparation: Prepare valid application along with validation reports with regional dtd 0.91Version
- eSub Identifier: Request for an eSubmission identifier from Thai Website (issued in 10 days of request and expires in 30 days)
- Delivery: Delivery of the application at Thai FDA in CD/DVD (make an prior appointment with HA at drug_esubmissions@fda.moph.go.th)
- Import: The eCTD will be validated and imported into the THAI FDA Review System
- Feedback: Application feedback (if there are problems experienced during the upload) and review of application by Thai FDA
THAI M1 Requirements
- Enhanced granularity for each sections
- Country code is not required in filenames
- Information relating to orphan market is not mandatory
- For LCM (Life cycle management) submissions the Operation attribute should be “Replace” in Tracking Table
- Validation report should be submitted along with the sequence
Media Formats To Be Used
Thai FDA has proposed a set of media formats to be used while submission of eCTD information as follows:
- (CD-R) i.e. Compact Disc-Recordable as per Joliet specification
- Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard
- Digital Versatile Disc-Recordable (DVD+R/-R) recorded in the Universal Disc Format
- (UDF) standard
Don’ts for Media Formats
- Double-sided discs
- Rewritable discs
- Compressed or zipped files (except for validation reports)
Important Points to Remember
- 1.3.1.3 Package Leaflet has been broken down into language sections for English, Thai and Other languages.
- It is recommended that separate files be submitted for each language.
- Applicants can re-use the content submitted in other regions (including STF).
- Prior to submitting the first sequence of an eCTD, an e-Submission Identifier must be assigned.
- The identifier must be entered as assigned in the envelope and should also to be used as the name for the application folder in which the sequence folders are submitted.
- The identifier is a combination of a letter and seven digits.
- Working documents are not needed and do not need to be provided within the eCTD framework for Thailand
- Section 1.5.2 has been broken down into three sections and given a section number to make expectations and cross referencing clearer.
- When responding to questions posed by the THAI FDA, a document addressing these questions should be provided. Where possible, hyperlinks should be created linking the topic addressed with the sections where changes have been made.
The primary component of eCTD submission is XML “backbone” file which offers metadata about content files. It also gives lifecycle instructions for explaining the submission and each document within the submission. Life sciences companies in Thailand should follow this data structure, as it greatly helps them with accurate submission of their documents at faster rate.
