Arpah Abas, BPharm
Member of International Editorial Advisory Board, GaBI Journal
Certified in Pharmacy
Former Deputy Director/Head of Biotechnology Section, Centre of Product Registration, National Pharmaceutical Control Bureau, Ministry of Health, Malaysia
Ms Arpah Abas was awarded her Bachelor of Pharmacy degree from the Western Australian Institute of Technology (now known as Curtin University), Perth, Australia.
Ms Abas was the Deputy Director/Head of Biotechnology Section, Centre of Product Registration, National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH), Malaysia until her retirement in May 2015. She has been instrumental in setting up the Biotechnology Section and is mainly responsible of the management and planning of activities of the Biotechnology Section of NPCB, developing, establishing and implementing policies, guidance documents and guidelines for the regulation of biopharmaceuticals, evaluation of application dossier for biologicals, participate in technical advisory meetings with related government agencies, institutions, industries and technical meetings in harmonisation of regulatory requirements amongst ASEAN member countries and OIC (Organisation of Islamic Cooperation) Member States.
She was responsible for the developments of all biological guidelines for registration of biological products in Malaysia. In particular, she is the principle author for the Guidance Document and Registration Guidelines for Biosimilars (2008) and Guidance Document and Registration Guidelines for Cell and Gene Therapy Products of Malaysia (2015).
Previously, Ms Abas was an Assistant Director in the Centre for Product Registration at the National Regulatory Authority of Malaysia (1990–2001). Between 1981 and 1990, she was a Lecturer (Lectures on Pharmacology to Pharmacy Assistant Students) at the School of Pharmacy Assistants, MOH, Malaysia, a Production Pharmacist (manufacture of parenterals and galenicals), an Analytical Pharmacist (quality control work in the quality laboratory), and a Procurement Pharmacist (in-charge of supplies and procurement in the warehouse and procurement department) at the Government Medical Laboratory and Store, Petaling Jaya, Malaysia. In addition, she was a Hospital Pharmacist (in-charge of the Pharmacy Department and procurement of drugs and medical supplies) at the National Leprosy Centre, Sungai Buloh, Malaysia (1980–1981).
Her areas of interest include: evaluation of medicinal products and biologicals/ biopharmaceuticals and biosimilars; advanced therapy medicinal products; nanotechnology and advanced drug delivery system; and regulatory collaboration and harmonisation.
Ms Abas is member Malaysian Pharmaceutical Society.