Representing the interests of API manufacturers in Australia

APIMAA was formed by the key API manufacturers in Australia in 1997, at the time when the introduction of a harmonized code of GMP for Active Pharmaceutical Ingredients (ICH Q7) was planned by global regulatory agencies. API manufacturers in Australia understood that for the industry to be acknowledged as a key stakeholder, and to be represented in Government policy development discussions, an industry association representing the interests of the API manufacturers had to be formed. Following incorporation of the Association and an introductory meeting with TGA’s National Manager, APIMAA was formally invited to be involved in policy development, and subsequently played a key role in the review of the ICH Q7 document. Over the years APIMAA has established and maintained an excellent working relationship with TGA, and is an active participant in the TGA – Industry consultation process as a member of the TGA - Industry working group on GMP (TIWGG).

Our objectives

• Represent the API industry in Government policy development discussions as a key stakeholder

• Promote the interests of API manufacturers in Australia

• Provide a technical, regulatory and compliance skills support network for members

• Raise the profile of the Australian API industry

• Provide a forum for members to share information on relevant international regulatory issues, and provide guidance on the actions required for effective compliance

• Actively participate in the review of regulatory guidelines and make submissions to Regulators

Office bearers

President Amy Nicol (Alkaloids of Australia)
Public Officer Stuart Smith (Phytex Australia)
Treasurer Rani Sabhavat (Phytex Australia)
Secretary Iziar Iriondo (Extractas Bioscience)

Executive Secretary Jurgen Lindner