Regulatory Inroads by GCC Health Authorities in Times of COVID19

Being a pharma regulatory expert in the GCC region and dealing with the relevant departments at the various health ministries, I am witnessing certain strategic steps taken by the various healthcare authorities to tackle the novel coronavirus (COVID-19).

While lockdown and sanitization will help to stem the spread of the virus among the citizens and residents, I am seeing that UAE, KSA and Bahrain are working swiftly to speed up imports and online registration processes at the time of writing this piece.

The regulatory authorities in Oman and Kuwait are also striving to speed up all processes to accept new submissions while Qatar has implemented a new electronic system for submission.

While I also believe that we may see some future initiatives on the regional level from the GCC Gulf Procurement Programme, let us look at the latest developments by country:

a) UAE: The new Law No. 8 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments of 2019 came into force on 30 January 2020 (published on 31/12/2019 in the official gazette). It applies to medicines, medical devices and health-related consumer goods and will be implemented within six months with a provision for a transitional period of a year.

While it will take time to impact the day-to-day business, the import division at MOHAP is working tirelessly to help companies import crucial health-care products such as masks and gloves but those that meet quality standards.

The UAE has also waived the legal registration of documents as it acknowledges the difficulties faced by the foreign companies to provide details from the country of origin under the current circumstances. The authority has also succeeded in streamlining new submissions through the portal.

b) Saudi Arabia: The Saudi Food and Drug Authority (SFDA) has implemented a fast-track clearance for all the registered product shipments related to COVID-19, with a commitment to register them in the near future. They have also allowed Whatsapp and Skype calls to speed up communication.

Furthermore, they have given a one-year’ grace period for authorized representatives to provide an attested agreement to register the required legal documents. Despite lean staffing, the SFDA is still accepting submissions but has stopped all exports of medicines, pharmaceuticals and medical equipment.

c) Oman and Kuwait: While both countries are working on submitted files, they are actively working to start a channel for new submissions. However, they are witnessing a huge rise in imports for all pharmaceuticals and medical devices necessary to tackle the virus.

In December 2019, Kuwait issued Ministerial Decree No. 361 of 2019 and the country is constantly working to raise the benchmarks in the healthcare sector in light of the current circumstances.

d) Bahrain: The National Health and Regulatory Authority (NHRA) has been very proactive and has issued a regulation to control the imports of COVID-10 kits that meet their regulatory standards and to be used only under their supervision.

According to a 7 April report in Gulf Weekly, an online publication, a 10-minute rapid coronavirus immunity test is expected to be available to hospitals as early as next week and the NHRA is currently reviewing three variants of the kits.

e) Qatar: The Qatar Health Authority has implemented a new online system for submission and it is working swiftly to to find a solution to submit NDA and all renewal files in e-CTD format.

It is important to note that yesterday, the GCC Health Council said that there is no new regulation or circular for COVID-19 but the organization is open to discuss files on a case-by-case basis.

So we need to watch and wait for updates from around the GCC as evidently the Gulf countries are keen to provide the best health measures possible for their citizens and residents and will leave no stone unturned to meet that aim.

Published by:

Mona Al Moussli

Co-founder PRA | Experienced pharma reg affairs consultant | MSc KREMS, Vienna | Middle-East MOH network

Published on: April 13, 2020

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