National Health Regulatory Authority (Bahrain)

Last updated
National Health Regulatory Authority
Nhra in sanabis.jpg
NHRA office in Al Khair Towers, Sanabis, Bahrain
Authority overview
Formed2010 (13 years ago)
Type Regulatory authority
Headquarters Sanabis, Manama
26°13′47″N50°32′46″E / 26.22971823747169°N 50.546066955443386°E / 26.22971823747169; 50.546066955443386 Coordinates: 26°13′47″N50°32′46″E / 26.22971823747169°N 50.546066955443386°E / 26.22971823747169; 50.546066955443386
Authority executive
  • Mariam Adhbi Al-Jalahma, CEO
Parent Authority Ministry of Health
Website www.nhra.bh

The National Health Regulatory Authority (NHRA) is an independent regulatory body established in 2010, under Law No. 38 of 2009, of the Kingdom of Bahrain. [1]

Contents

Bahrain's hospitals, medical centres, pharmacies, physicians, surgeons, nurses, pharmacists, medical technicians and allied healthcare institutions and healthcare professionals must be registered with, and/or licensed, by NHRA.

Mission, vision and goals

According to the NHRA's website, its mission is "to regulate the provision of healthcare in Bahrain and ensure appropriateness, continuity, efficiency and safety in delivering health services, both in the governmental and private sector. It will be based on the best scientific evidence and healthcare best practices, in accordance to international standards". [1]

As per the authority's statements NHRA's Vision is "to ensure safe and high quality in the delivery of healthcare in the kingdom". [1]

Its strategic goals include the regulation and accountability of all healthcare facilities so that they meet the required standards for licensing, the continuous monitoring of the quality of the provision of health services - to ensure compliance with evidence-based practices and accreditation standards - and the preservation and protection of patients' health rights, as well as the rights and the safety of all people who use the health care facilities.

NHRA's responsibilities listed on its official website are: (1) Issue regulations and executive decisions concerning the organization of professions and health services (2) Grant and renew licences for health professionals and healthcare facilities (3) Investigate patients complaints (3) Determine the terms and conditions for the use of health care informatics (4) Monitor, evaluate and accredit healthcare facilities (5) Undertake disciplinary hearings of licensees regarding professional misconduct (6) Approving clinical trials (7) Registration and licensing of medical devices (8) Setting the rules for drug registration and pricing, and ensure the quality of medicines and pharmaceuticals. [2]

On 4 July 2020, in an online lecture for the Shura Council on health sector legislation, the Chief Executive Officer of NHRA Dr Mariam Al Jalahma said that NHRA is responsible "for the implementation and development of health regulations in both governmental and private sectors in Bahrain. This involves regulatory procedures related to licensing health care facilities as well as licensing health care professionals within them". [3]

Leadership and policy

The CEO Dr Mariam Al Jalahma mentioned in her interview to the Oxford Business Group that NHRA ensures that there are no malpractices in the import of medical equipment and essential drugs. According to her, NHRA also verifies the authenticity of degrees and certificates of healthcare professionals like nurses, doctors and pharmacists, before licensing them to work in Bahrain. [4]

During an online lecture, organized by the Bahrain Institute for Public Development (BIPD) for the Shura Council, on health sector legislation and the role of the NHRA on 4 July 2020, Dr Mariam Al Jalahma had said that NHRA is ready "to receive patient complaints about medical and professional errors and to investigate them. It is also ready to receive reports about medical and professional errors and serious accidents by institutions in order to ensure action is taken, to improve performance and to take disciplinary measures against health guilty professions practitioners". [3]

The Chief Executive Officer of NHRA, Dr. Mariam Adhbi Al-Jalahma, is listed among the 100 Most Influential Arab Personalities in the field of social responsibility in 2020, by the Regional Network for Social Responsibility. [5] [6] The honouring is in recognition of Dr. Al-Jalahma’s key role in promoting the social responsibility culture. [5]

Response to Covid-19

In December 2020, NHRA announced it has officially approved the registration of Sinopharm’s COVID-19 vaccine after the submission of all related documentation by G42 Healthcare, the company's exclusive distributor in the Middle East and North Africa. [7] And with NHRA's approval of Pfizer-BioNTech COVID-19 Vaccine, Bahrain became the second country in the world to grant an Emergency Use Authorisation (EUA) for the vaccine. [8]

On 25 January 2021, the National Health Regulatory Authority (NHRA) announced that it approved the emergency use of the Oxford–AstraZeneca COVID-19 vaccine manufactured by the Serum Institute of India under the name ‘Covishield’. [9] [10]

The fourth Vaccine approved by Bahrain’s NHRA is Sputnik V COVID-19 vaccine. [11]

The National Health Regulatory Authority (NHRA) has also authorized, as the fifth vaccine, the emergency use of Janssen COVID-19 vaccine from Johnson and Johnson. [12] Bahrain became the first country in the world to approve this particular vaccine. [13]

See also

Related Research Articles

Health Canada is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of healthcare, agricultural, and pharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and pharmaceutical products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods.

The COVID-19 pandemic in Bahrain is part of the worldwide pandemic of coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2. The virus was confirmed to have reached Bahrain on 21 February 2020.

<span class="mw-page-title-main">Oxford–AstraZeneca COVID-19 vaccine</span> Viral vector vaccine for prevention of COVID-19 by Oxford University and AstraZeneca

The Oxford–AstraZeneca COVID‑19 vaccine, sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed in the United Kingdom by Oxford University and British-Swedish company AstraZeneca, using as a vector the modified chimpanzee adenovirus ChAdOx1. The vaccine is given by intramuscular injection. Studies carried out in 2020 showed that the efficacy of the vaccine is 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose, and 81.3% after the second dose. A study in Scotland found that, for symptomatic COVID-19 infection after the second dose, the vaccine is 81% effective against the Alpha variant, and 61% against the Delta variant.

<span class="mw-page-title-main">COVID-19 vaccination in Switzerland</span> Plan to immunize against COVID-19

COVID-19 vaccination in Switzerland is an ongoing immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country.

The COVID-19 vaccination program in the Philippines is an ongoing mass immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country. The vaccination program was initiated by the Duterte administration on March 1, 2021, a day after the arrival of the country's first vaccine doses which were donated by the Chinese government.

<span class="mw-page-title-main">Janssen COVID-19 vaccine</span> Vaccine against COVID-19

The Janssen COVID‑19 vaccine, sold under the brand name Jcovden, is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson.

<span class="mw-page-title-main">COVID-19 vaccination in India</span> Immunisation programme against COVID-19 in India

India began administration of COVID-19 vaccines on 16 January 2021. As of 2 December 2022, India has administered over 2.19 billion doses overall, including first, second and precautionary (booster) doses of the currently approved vaccines. In India, 95% of the eligible population (12+) has received at least one shot, and 88% of the eligible population (12+) is fully vaccinated.

<span class="mw-page-title-main">History of COVID-19 vaccine development</span> Scientific work to develop a vaccine for COVID-19

SARS-CoV-2, the virus that causes COVID-19, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering the urgent international response to prepare for an outbreak and hasten development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.

<span class="mw-page-title-main">European Commission–AstraZeneca COVID-19 vaccine dispute</span> Dispute between the European Union and AstraZeneca

A dispute broke out in January 2021 between the European Commission and the pharmaceutical company AstraZeneca AB about the provision of COVID-19 vaccines during the COVID-19 pandemic, and, in February, spilled out into a dispute over Article 16 of the Northern Ireland Protocol. Vaccination proceeded apace in the UK but more slowly in the EU, and by the end of March 2021, over 30% of the UK population had received at least one dose of vaccine compared to about 8% of the EU population. This was partly due to limited availability of the AstraZeneca vaccine in the EU. The World Health Organization and the European Medicines Agency continued to state that the vaccine was safe and effective. However, a representative of the European Medicines Agency said in June that vaccines based on the mRNA technology should be preferred if available for all age groups, including for the over 60s.

<span class="mw-page-title-main">Ministry of Health (Bahrain)</span>

The Ministry of Health is responsible for providing integrated preventive and curative health services, through a network of primary, secondary and tertiary health care facilities, in the Kingdom of Bahrain. These healthcare services are provided in coordination with other ministries, private sector and the community.

<span class="mw-page-title-main">COVID-19 vaccination in the Republic of Ireland</span> Immunisation plan against COVID-19

The COVID-19 vaccination programme in the Republic of Ireland is an ongoing mass immunisation campaign that began on 29 December 2020 in response to the COVID-19 pandemic in the Republic of Ireland. Ireland's vaccination rollout has been praised as one of the most successful rollouts in the world and was ranked number one in the European Union in terms of its percentage of adult population fully vaccinated, and was also ranked number one in the EU for the number of booster vaccines administered.

<span class="mw-page-title-main">COVID-19 vaccination in Canada</span> COVID-19 vaccination programme in Canada

COVID-19 vaccination in Canada is an ongoing, intergovernmental effort coordinated between the bodies responsible in the Government of Canada to acquire and distribute vaccines to individual provincial and territorial governments who in turn administer authorized COVID-19 vaccines during the COVID-19 pandemic in Canada. Provinces have worked with local municipal governments, hospital systems, family doctors and independently owned pharmacies to aid in part, or in full with vaccination rollout. The vaccination effort in full is the largest such immunization effort in the nation's history. The vaccination effort began December 14, 2020, and is currently ongoing.

<span class="mw-page-title-main">Embolic and thrombotic events after COVID-19 vaccination</span> Post vaccination adverse effects

Post-vaccination embolic and thrombotic events, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), thrombosis with thrombocytopenia syndrome (TTS), vaccine-induced immune thrombocytopenia and thrombosis (VITT), or vaccine-associated thrombotic thrombocytopenia (VATT), are rare types of blood clotting syndromes that were initially observed in a number of people who had previously received the Oxford–AstraZeneca COVID‑19 vaccine (AZD1222) during the COVID‑19 pandemic. It was subsequently also described in the Janssen COVID‑19 vaccine leading to suspension of its use until its safety had been reassessed. On 5 May 2022 the FDA posted a bulletin limiting the use of the Janssen Vaccine to very specific cases due to further reassesment of the risks of TTS, although the FDA also stated in the same bulletin that the benefits of the vaccine outweigh the risks.

<span class="mw-page-title-main">COVID-19 vaccination in South Korea</span> Plan to immunize against COVID-19

COVID-19 vaccination in South Korea is an ongoing immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country.

<span class="mw-page-title-main">COVID-19 vaccination in Bangladesh</span> Immunisation programme against COVID-19 in Bangladesh

Bangladesh began the administration of COVID-19 vaccines on 27 January 2021 while mass vaccination started on 7 February 2021.

<span class="mw-page-title-main">COVID-19 vaccination in Brazil</span> Plan to immunize against COVID-19

The COVID-19 vaccination campaign in Brazil is an ongoing mass immunization campaign for the COVID-19 pandemic in Brazil. It started on January 17, 2021, when the country had 210 thousand deaths.

<span class="mw-page-title-main">Tixagevimab/cilgavimab</span> Experimental monoclonal antibody treatment for COVID-19

Tixagevimab/cilgavimab, sold under the brand name Evusheld is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections.

References

  1. 1 2 3 "NHRA Overview". NHRA. National Health Regulatory Authority. Retrieved 9 January 2021.
  2. "NHRA Mission". NHRA. National Health Regulatory Authority. Retrieved 9 January 2021.
  3. 1 2 "Health sector legislation highlighted at virtual conference". Ministry of Information Affairs. Bahrain News Agency. 4 July 2020. Retrieved 21 February 2021.
  4. "Bahrain-Health Interview with CEO of NHRA". Oxford Business Group. Oxford Business Group. Retrieved 9 January 2021.
  5. 1 2 "Prestigious honour for NHRA chief". Dar Akhbar Al Khaleej Press and Publishing. Gulf Daily News. 28 January 2021. Retrieved 28 January 2021.
  6. "NHRA chief among 100 most influential Arab persons in social responsibility 2020". Ministry of Information Affairs. Bahrain News Agency. 28 January 2021. Retrieved 28 January 2021.
  7. "National Health Regulatory Authority approves Sinopharm COVID-19 vaccine". Bahrain News Agency. Bahrain News Agency. Retrieved 9 January 2021.
  8. "Bahrain second in the world to approve the Pfizer/BioNTech Covid-19 vaccine". Bahrain News Agency. Bahrain News Agency. Retrieved 9 January 2021.
  9. "Bahrain authorizes the emergency use of Oxford/AstraZeneca vaccine, manufactured by the Serum Institute of India". Ministry of Information Affairs. Bahrain News Agency. 25 January 2021.
  10. Nagraj, Aarti (27 January 2021). "Bahrain has approved the emergency use of Oxford-AstraZeneca Covid-19 vaccine". Motivate Media Group. Gulf Business. Retrieved 27 January 2021.
  11. "Bahrain authorizes Sputnik V COVID-19 vaccine for emergency use". Saudi Research & Publishing Company. Arab News. 11 Feb 2021. Retrieved 17 February 2021.
  12. "Bahrain authorizes emergency use of Janssen Covid-19 Vaccine". Ministry of Information Affairs. Bahrain News Agency. 25 Feb 2021. Retrieved 3 March 2021.
  13. "Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use - regulator". Thomson Reuters. Reuters. 25 Feb 2021. Retrieved 3 March 2021.