ASEAN Common Technical Dossier (ASEAN CTD or ACTD)


ASEAN is a geo-political and economic organization of ten countries located in Southeast Asia, which was originally formed on August 8, 1967 by Indonesia, Malaysia, Singapore and Thailand. Since then the membership has extended to Brunei, Myanmar, Philippines, Cambodia, Laos PDR and Vietnam. As of 2012 the ASEAN region has a population of about 600 million and combined gross domestic product of PPP (Purchasing Power Parity) US$3.62 trillion.

EMA announces the launch of the International Generic Drug Regulators Pilot (IGDRP)

A step towards Global Regulatory Harmonisation?


Regulatory Authorities are facing an increasing workload as a result of the growing number of generic applications on one hand, and the demand for accessible, lower-cost quality medicines on the other.

In an attempt to address this issue, Regulatory Authorities have tried to set the grounds for collaboration, towards a faster mechanism for the approval of generic products. As a result, the International Generic Drug Regulators Pilot (IGDRP) was launched in 2012, with the participation of the Regulatory bodies of EU (EMA), USA, Canada, Australia, Singapore, Switzerland, Brazil, China, Chinese Taipei, Republic of Korea, Japan and Mexico. Since its first launch, the Regulatory bodies of New Zealand, Russia and South Africa have also joined the IGDRP.

Turkish approach to bringing Biosimilars to Market

Turkish FlagTurkey is the 6th largest pharmaceutical market in Europe and the 16th largest pharmaceutical market in the world, and is classed as one of the fastest growing emerging markets. Pharmaceutical companies in Turkey have started to specialize in biotechnology based treatments due to increasing and changing health demands in Turkey as well as other pharmemerging markets. In Turkey, an applicant who intends to obtain approval of a “biosimilar product” must submit an “abridged” application to the General Directorate of Pharmaceuticals and Pharmacy.  In the same way as an application in the EU, the applicant should demonstrate the similarity of the biosimilar product to the reference product (already authorized original biological product) in terms of its quality, characteristics, biological activity, safety and efficacy. In addition, the clinical trial data can be presented from clinical trials undertaken outside of Turkey, with the relevant approval from the competent authority.

Oncology Products – Barriers to Success

oncologyCancer is the leading cause of death in UK and as consequence extensive research has been conducted into potential cures and treatments.

Certainly, it is clear that cancer is a very complex and dynamic disease with vast numbers of different types of cancers, nearly all of them currently incurable.

INFARMED’S Pre-Submission Portal for New Marketing Authorisation Applications

Updated user’s guidance issued on February 2014
Portugal_flag_300In August 2013, INFARMED introduced a new electronic portal for pre-submission of new Marketing Authorisation Applications (Medicinal Products for Human Use Management System-MAA: SMUH-AIM). The use of the portal became mandatory on November 4th for all applications through a national procedure, a Repeat-Use Procedure where Portugal would act as the RMS or a Mutual Recognition/Decentralised procedure where Portugal would act as an RMS or CMS.