CPP Certificate of Pharmaceutical Product: What Thailand Importers Need to Know
The Certificate of Pharmaceutical Product (CPP) is a mandatory document for most drug registrations in Thailand. This guide explains what it is, who issues it, and how Taiwan exporters provide it.
What Is a Certificate of Pharmaceutical Product (CPP)?
A Certificate of Pharmaceutical Product (CPP) is an official document issued by the pharmaceutical regulatory authority in a drug's country of manufacture. It certifies that a specific pharmaceutical product is authorized for sale in the country of origin.
The CPP format follows the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, and it is widely required by regulatory authorities worldwide — including Thailand FDA — as part of the import drug registration process.
Why Thailand FDA Requires a CPP
For imported pharmaceutical products, Thailand FDA uses the CPP as evidence that:
- →The product is manufactured in a facility that meets GMP standards recognized in the country of origin
- →The product is legally marketed and approved in the manufacturer's home country
- →The regulatory authority in the exporting country (e.g., TFDA) stands behind the product's quality and registration status
Without a valid CPP, most imported pharmaceutical applications to Thai FDA cannot proceed.
Who Issues the CPP for Taiwan-Manufactured Products?
For pharmaceutical products manufactured in Taiwan, the CPP is issued by the Taiwan Food and Drug Administration (TFDA), which operates under the Ministry of Health and Welfare (MOHW).
TFDA issues CPPs under the WHO Certification Scheme format — confirming that the named product is registered and approved for sale in Taiwan.
What Information Does a CPP Contain?
A standard CPP issued by TFDA includes:
- →Product name (INN and brand name if applicable)
- →Dosage form and strength
- →Active and inactive ingredients
- →Manufacturer name and address
- →Statement of marketing authorization status in Taiwan
- →GMP compliance statement
- →Any conditions or restrictions on the authorization
- →Issuing authority signature and stamp
CPP Validity and Renewal
CPPs are typically issued with a limited validity period — commonly 1–2 years. Thailand FDA requires that the CPP submitted must be currently valid at the time of submission.
Taiwan exporters with established TFDA relationships can typically obtain a new CPP within 4–8 weeks of application.
CPP vs GMP Certificate: Key Difference
| GMP Certificate | CPP | |
|---|---|---|
| Covers | Manufacturing facility | Specific product |
| Scope | All products at the facility | One product / strength / form |
| Purpose | Facility quality standard | Product registration status |
Both are required for Thailand FDA registration. They serve different functions and cannot substitute for each other.
Practical Tips for Thailand Importers
- →Request the CPP early in your supplier evaluation — before committing to a registration project
- →Confirm the CPP covers the exact product name, strength, and dosage form you intend to register
- →Check the expiry date: if registration will take 18–24 months, you may need to renew the CPP mid-process
- →Keep a copy of the CPP issuance application on file
Summary
The CPP is a foundational document for importing pharmaceutical products into Thailand. Working with Taiwan exporters who maintain current TFDA registrations and can promptly provide CPP documentation significantly simplifies the Thailand FDA registration process.
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