Australia’s TGA CPPs Open Doors to Global Pharmaceutical Markets

Pharmaceutical companies seeking to register products internationally must navigate a range of regulatory requirements — and a key tool in this process is the Certificate of Pharmaceutical Product (CPP) issued by the Therapeutic Goods Administration (TGA), the Australian health authority.

A CPP is an official document confirming the regulatory status of a medicine approved for supply in Australia. It provides essential information about product approval, manufacturing site compliance (GMP), and marketing status. Many health authorities around the world, particularly those aligned with WHO certification standards, accept CPPs as part of the submission package for registering new medicines.

Australia’s TGA is widely regarded as a high-standard regulator, and a TGA-issued CPP is often a trusted and efficient route for supporting overseas registrations. This is especially valuable for companies seeking to expand into markets where reliance on trusted reference agencies is part of the local registration process.

In the JAPAC region, countries such as China, Vietnam, the Philippines, Macau, Hong Kong, Taiwan, Myanmar, Cambodia, Indonesia, Laos, Thailand, and Bangladesh commonly reference TGA-issued CPPs to streamline evaluation processes, reduce review timelines, or satisfy regulatory reliance requirements. Leveraging a TGA CPP can therefore significantly accelerate access to these key emerging markets and support broader regional expansion strategies.

Beyond Asia-Pacific, the value of a TGA CPP extends across South Asia, Latin America, sub-Saharan Africa, the Middle East and North Africa (MENA), with regulators in these regions frequently requiring or accepting CPPs as part of their marketing authorisation submissions.

To make the most of a CPP, it’s important to ensure that supporting documentation — such as GMP certificates, product information, and labelling — aligns with the expectations of the destination country. Each market may also have specific requirements regarding the format, language, and validity period of the CPP.

For companies planning global launches or pursuing sequential approvals in multiple jurisdictions, including a TGA CPP in the registration strategy can offer speed, clarity, and regulatory confidence. Whether used as a primary reference or in combination with other documents, CPPs are a flexible and credible solution for supporting medicine registrations worldwide.