EuroMeeting Globalisation Track: International collaboration in the review of Generic Drugs

Chair(s):Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Description:
With the globalisation trend, an increasing number of generic medicines manufacturers are keen to introduce their products at global scale. For health authorities, a need for fast supply of medicinal products from other markets may occur in case of unexpected shortages in their region. Single development program and more harmonised assessments of generic medicinal products between various markets in order to avoid unnecessary duplications of effort shall be discussed among the authorities and industry.

Presentation(s) & Speaker(s):
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
Federal Institute for Drugs and Medical Devices, Germany

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike D. Ward
Manager, International Programs Division
Health Canada, Canada

for more Globalisation track sessions see Theme 13...

IFPMA - Policies that Encourage Innovation in Middle-income Countries - report by Charles River Assoc

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) asked Charles River Associates (CRA) to investigate the conditions necessary to encourage innovation in middle-income countries. Ultimately, the purpose of this project is to evaluate the policies of host governments that encourage investment in innovative activities and the implications for future innovation policy.

The report focuses on eight case study countries (Brazil, China, Colombia, India, Malaysia, Russia, South Africa and South Korea). The case studies were chosen using a number of criteria. Firstly, we selected countries from different geographic regions, focusing on those that had been most successful in developing innovative activities to date in their region. Secondly, we chose countries that illustrate a range of different policy approaches. Thirdly, we chose a mix of countries with a long-standing objective of developing an innovative industry as well as countries that had only relatively recently embarked on this. Finally, we included South Korea as a basis of comparison, which was a middleincome country when it instigated its programme to encourage pharmaceutical innovation and provides a longer term perspective on what is achievable.

In addition, to reviewing the existing academic literature and government sources, we undertook 25 interviews with government officials, academics, industry trade associations and individual companies.