Tag: Regulatory & Policy

African Medicines Agency set in motion following 15 enactments from member states

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GABON – The Republic of Gabon has become the 14th member state to deposit the instrument of ratification of the African Medicines Agency (AMA) to the AU Commission  after endorsing it on the 1st October 2021. The African Medicines Agency (AMA) is a proposed specialized agency of the African Union (AU) intended to facilitate the harmonization of medical regulation throughout the African Union. AMA aims to provide support for the improvement of weak regulatory systems. AMA will, among other functions, coordinate and strengthen ongoing initiatives to harmonize medical products regulation…

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SAPHRA approves Neoteryx’s Mitra devices for blood specimen collection

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SOUTH AFRICA – The Mitra micro sampling device from US-based Neoteryx has been approved as a Class B in vitro diagnostic (IVD) medical device by the South African Health Products Regulatory Authority (SAHPRA) in South Africa. Separations, a South African-based distributor of devices and products for scientists and labs, helped get the Mitra device approved for broad use in South Africa. Class B registration allows lay people to use the Mitra to self-sample at home for research studies or monitoring non-critical conditions. The Mitra device is ideal for remote use…

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New global meningitis strategy aims to save 200,000 lives a year

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SWITZERLAND – The World Health Organization (WHO) is aiming to eliminate the deadliest form of meningitis by 2030 through increased awareness and access to treatments, global plans launched by the UN-agency to combat the inflammatory disease showed. Meningitis is a dangerous inflammation of the membranes surrounding the brain and spinal cord. While it is typically caused by bacterial and viral infections, bacterial meningitis kills more people than any other form of the disease. The most serious form of the disease tends to be caused by bacterial infection. It leads to…

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Nairobi based Hospital license revoked amid claims of violating Covid jab protocols

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KENYA – The Kenya Medical Practitioners and Dentists Council (KMPDC) has revoked the operating license of Ruai Family Hospital, a pace setting private facility in Nairobi, following alleged violation of COVID-19 Vaccination regulations. According to the council, the hospital, which had been designated as a COVID-19 Vaccination Centre, has been diverting vaccines to other unauthorized premises. The Council said it had received credible information that the Ruai Family Hospital which is designated as a COVID-19 Vaccination Centre had contravened the rules and regulations governing the COVID-19 deployment and diverted vaccines…

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India grants approval to ZyCoV-D, first ever DNA based COVID-19 vaccine

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INDIA – The world’s first DNA-plasmid vaccine, the three-dose one for Covid-19 developed by Cadila Healthcare (Zydus Cadila), has received emergency-use authorization from the Drugs Controller General of India (DCGI) for use in adolescents 12 years old and above. “It is a matter of great pride that today we have EUA for the world’s first DNA Covid-19 vaccine, ZyCoV-D, by Zydus, developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha,” Renu Swarup, secretary, department of biotechnology, and chairperson, Biotechnology Industry Research Assistance Council, said. This…

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UIA licenses Wondfo Biotech, world’s leading medical diagnostic manufacturer

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UGANDA – In an effort to promote investments in the pathogenic industry, Uganda Investment Authority (UIA) has offered an investment license to one of the world’s biggest and fastest growing manufacturers of medical diagnostic products, Guangzhou Wondfo Biotech Co. Ltd. The company is setting shop in Uganda to manufacture pharmaceuticals, medicinal chemicals and botanical products, the implication being that it would utilize locally sourced raw materials. Founded in 1992, Guangzhou Wondfo Biotech Co. Ltd. is one of the fastest growing point of care diagnostic testing (POCT) manufacturers in the world.…

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Roche gets approval for diagnostic tumor test as WHO warns unfair distribution of COVID-19 Arthritis drug

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SWITZERLAND – Roche has received approval from the U.S. Food and Drugs Administration for its Ventana MMR RxDx panel, a diagnostic test to help identify patients with solid tumors which could turn cancerous. The test evaluates a panel of DNA mismatch repair (MMR) proteins in tumors to provide important treatment information to clinicians, the company said. When MMR is deficient, cells mutate which can lead to cancer. Even as the Swiss drug maker celebrates this milestone, the World Health Organization has called on the company to ensure fair distribution of…

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U.S. FDA declines to approve FibroGen’s anemia drug citing insufficient trial data

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USA – FibroGen Inc said has announced that the U.S. Food and Drug Administration has declined to approve its treatment for anemia of chronic kidney disease, citing the need for an additional clinical study. Last month, a panel of experts to the FDA voted against the approval of the company’s drug candidate, roxadustat, which the company is developing in partnership with AstraZeneca. FibroGen shares slipped 2.5% to $12.9 before the bell following the negative decision by the regulator. Ahead of the expert panel meeting, the FDA had raised concerns about…

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Zydus Cadila anticipates emergency use approval for its COVID-19 vaccine

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INDIA – In what will be the first COVID-19 jab for the adolescent population in India, the Zydus Cadila vaccine expects to get a nod from the Indian regulatory centre this week. Zydus Cadila’s jab will be the sixth COVID-19 vaccine to get approved in India after Covishield, Covaxin, Sputnik V, Moderna and J&J, which was the latest to get DGCI approval. ZyCoV-D is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system. It can be stored at 2-8 degree Celsius but has shown good stability at…

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Johnson and Johnson COVID-19 vaccine granted emergency use approval in India

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INDIA – Johnson & Johnson’s single-dose COVID-19 vaccine has been given Emergency Use approval in India, Union Health minister Mansukh Mandaviya announced. He said this will further boost the country’s collective fight against the novel coronavirus infection. “India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has five EUA vaccines. This will further boost our nation’s collective fight against,” the minister tweeted. The US-based pharmaceutical company had applied for Emergency Use Authorization for its jab on Friday and…

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