Certificate of Pharmaceutical Product (CPP): Implementation and additional requirements in Asian and African countries
The Certificate of Pharmaceutical Product (CPP) is a document based on a format recommended by WHO which establishes the status of a pharmaceutical product and of the applicant for this certificate in the exporting country. Its implementation enhances the availability of new drugs in developing countries. However, despite the standard format, each country has its own additional requirements. The objective of this poster is to display the additional requirements among 23 Asian and 11 African countries.
The regulatory requirements of certain Asian and African countries as implemented between 2019 and 2021 were collected. The countries in scope from Asia were: Cambodia, Bangladesh, Kazakhstan, Indonesia, Malaysia, Philippines, Iraq, Russia, Macao, Lebanon, Sri Lanka, Belarus, Vietnam, Oman, United Arab Emirates, Qatar, Bahrain, Kuwait, Taiwan, Nepal, India, Myanmar, Jordan. The countries in scope from Africa were: Libya, Egypt, Uganda, Nigeria, Ghana, Mauritius, Kenya, Rwanda, Zambia, Ethiopia, Tanzania.
After examining the additional requirements of each country, the results for Asia were as follows; 1 country (Iraq) requires the statement of the shelf-life in addition to the CPP. 19 countries (Cambodia, Bangladesh, Indonesia, Malaysia, Iraq, Macao, Lebanon, Sri Lanka, Belarus, Vietnam, Oman, United Arab Emirates, Qatar, Kuwait, Taiwan, Nepal, India, Myanmar, Jordan) require the statement of the marketing status as well as the marketing date of the respective product in the exporting country. 13 countries (Jordan, India, Nepal, Kuwait, Bahrain, Qatar, United Arab Emirates, Oman, Sri Lanka, Iraq, Philippines, Indonesia, Bangladesh) require the Summary of Product Characteristics and/or the Patient Information Leaflet in the exporting country (preferably as an English translation). 3 countries (Myanmar, India, Macao) require notarized CPP. 9 countries require embassy legalization of the CPP in the exporting country (Jordan, Taiwan, Kuwait, Qatar, United Arab Emirates, Vietnam, Lebanon, Iraq, Bangladesh) while 5 countries (Bahrain, Oman, Belarus, Russia, Kazakhstan) require legalization of the CPP via Apostile.
As far as Africa is concerned the results were as follows; 10 countries (Libya, Uganda, Nigeria, Ghana, Mauritius, Kenya, Rwanda, Zambia, Ethiopia, Tanzania) require the statement of the shelf-life in addition to the CPP. 11 countries (Libya, Egypt, Uganda, Nigeria, Ghana, Mauritius, Kenya, Rwanda, Zambia, Ethiopia, Tanzania) require the statement of the marketing status and the marketing date of the product as well as the Summary of Product Characteristics and/or the Patient Information Leaflet in the exporting country (preferably as an English translation). 6 countries (Libya, Egypt, Nigeria, Zambia, Ethiopia, Tanzania) require embassy legalization of the CPP in the exporting country. 5 countries (Uganda, Ghana, Mauritius, Kenya, Rwanda) require legalization of the CPP via Apostile.
As a conclusion, the Certificate of Pharmaceutical Product as recommended by WHO is an established document format and regulatory pathway that despite the various additional requirements from country to country it ensures and facilitates access for patients in developing countries to novel and innovative treatment options.

Certificate of Pharmaceutical Product (CPP): Implementation and Additional Requirements in Asian and African Countries

DIA Europe 2022

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