Improvement of regulatory generic and biosimilar medicines landscape for 2020 for patient needs

On 28.01.2016, the European Generic and Biosimilar Medicines Association (EGA), a member of which is the Bulgarian Generic Pharmaceutical Association (BGPharmA), held the 15th Regulatory and Scientific Affairs Conference where representatives of 61 regulators from 25 countries made progress in improving the generic and biosimilar regulatory landscape for patient needs. The 2020 European Medicines Agency /EMA/ Strategy, complemented by the 2020 Strategy Paper of the Coordination Group for Mutual Recognition and Decentralised Procedures will pursue operational excellence in the EU Regulatory Network and engagement in international regulatory platforms which will ultimately deliver greater value to public health. The generic and biosimilar medicines industries presented a number of regulatory improvements in the EGA Regulatory Efficiency report in support of the 2020 strategies. Promoting high-standard global regulatory convergence, supporting a single development programme for generic and biosimilar medicines and optimising the scope of regulatory processes supported by telematics tools will contribute to better access for better health by 2020. Adrian van den Hoven, Director General of the European Generic and Biosimilar Medicines Association (EGA), said: „this event provides an invaluable platform for manufacturers, regulators and stakeholders to improve regulatory efficiency so that our industries can deliver better access to high quality medicines in the future.“