KT Network

Summit discusses latest regulations and best practices in GCC pharmaceuticals sector

Filed on April 10, 2021

Government authorities in the Gulf region and leading healthcare solutions providers recently came together at the sixth GCC Regulatory Affairs Pharma Summit to discuss regulations and best practices relating to drug registration and approvals in the region.

The two-day virtual summit supported by the UAE Ministry of Health and Prevention was aimed to showcase new developments in the pharmaceuticals sector in GCC as well as their impact on improving patient access to medicines.

Over 300 professionals from public health authorities and the pharmaceutical supply chain attended the summit in which 50 regional and international experts shared insights on topics relevant to regulatory affairs, legal and compliance aspects of drug registration and approvals.

Dr Amin Hussain Al Amiri, assistant undersecretary for public health policy and licensing sector in the UAE Ministry of Health and Prevention, in his keynote address on the opening day of the summit, highlighted the importance of maintaining and updating effective health legislation that would ensure a prompt and timely response to emerging healthcare challenges, such as the ones posed by the Covid-19 pandemic."

"In the UAE, we adopt an open-door policy and efficient processing of regulatory and legislative requirements related to healthcare delivery. The approach was critical in the UAE pioneering a robust response to COVID-19 and extending support internationally to withstand and overcome the pandemic challenge," Dr Al Amiri said.

"Some of the changes we have known recently are likely to remain post-Covid-19," added Dr Al Amiri.

The summit had sessions focused on the most important factors influencing pharmaceutical regulations and drug safety in the GCC States as well as internationally, including track and trace and serialisation; market access and pricing; e-labelling; lifecycle management; biosimilars, and electronic common technical document (eCTD).

One of the sessions also had speakers evaluating the near to long term impact of Covid-19 on healthcare and pharmaceuticals in GCC. The pandemic has called for new solutions and faster responses in the region when the high prevalence of lifestyle diseases and an ageing population are already driving demand for healthcare and pharmaceuticals. An estimate by Alpen Capital in 2020 showed per capita healthcare expenditure in GCC at $1,147.80, higher than the global average of $1,059.

"The sixth GCC Regulatory Affairs Pharma Summit comes in the backdrop of the first anniversary of Covid-19, which in fact underscored the importance of optimising market access for pharmaceuticals and simplifying drug registration and approvals. We are grateful to the UAE Ministry of Health and Prevention, Oman Ministry of Health, Kuwait Ministry of Health, National Health Regulatory Authority in Bahrain and all our valuable partners for facilitating this forum," said Dr Najiba Al Shezawy, co-founder and director general at PRA Consultancy, the organiser of the summit.


Dr Mona Al Moussli, Managing Director at PRA Consultancy, added: "The GCC Regulatory Affairs Pharma Summit has had a key role in supporting health authorities and professionals across the region to analyse future trends and embrace change. It's an opportunity for the pharma companies to understand the many nuances in regulations and compliance in the various GCC States and for health authorities to share knowledge and practices."

The summit had government regulators from Kurdistan and Jordan as invitees in Jordan. A series of round tables, networking sessions and an exhibition zone was also part of the programme.




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