{"id":39959,"date":"2022-11-07T19:31:17","date_gmt":"2022-11-07T19:31:17","guid":{"rendered":"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi"},"modified":"2022-11-07T20:02:16","modified_gmt":"2022-11-07T20:02:16","slug":"analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi","status":"publish","type":"post","link":"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi","title":{"rendered":"ANALYSIS | 3 ways Covid sped up SA&#8217;s medicine approvals process \u2014 and how it can help the NHI"},"content":{"rendered":"<p><span style=\"color: #ff6600\"><strong>Africa-Press &#8211; Uganda. <\/strong><\/span>During the Covid-19 pandemic, the South African Health Products Regulatory Authority (Sahpra) was forced to speed up its review of new medicines, such as vaccines, while still ensuring that they were safe and effective, writes <b>Portia Nkambule.<\/b><\/p>\n<p>A leap year comes around every four years. As does the Olympics. And in the past, likely an approval of a new medicine by the South African Health Products Regulatory Authority (Sahpra).<\/p>\n<p>But the Covid pandemic shook things up \u2014 and for the better in the case of getting Sahpra-approved medicines and other health products such as diagnostic tests onto the market.<\/p>\n<p>Before Covid, it could take Sahpra three to four years to approve a new product because the regulator was steadily working through a huge backlog of applications. This was because, at the time, rules for medicine approvals required us to prioritise applications for products that contain an ingredient that&#8217;s on the government&#8217;s essential medicines list. And because there are many generic versions of such products, too, the number of applications that needed to be dealt with piled up. The rules have since been amended, so this condition doesn&#8217;t apply anymore.<\/p>\n<p>During the pandemic, though, we were able to cut the review process of Covid-19 vaccines down to between four and 11 months \u2014 on average five times faster than before \u2014 without compromising our assessment standards. Moreover, during this time, we continued to also prioritise approvals of products such as HIV prevention medicines, antiretrovirals for HIV, TB and cancer (this process was in place before Covid), in addition to Covid treatments and vaccines.<\/p>\n<p>How? By streamlining how we work.<\/p>\n<p><b>Go inside Sahpra in a do-or-die moment<\/b><\/p>\n<p>The pandemic was a do-or-die moment at Sahpra. Because of the public health emergency, many more applications landed on our desks than before, on top of the long backlist of applications \u2014 but our staff numbers stayed the same. This pushed us to work smarter so that our processes would not only speed up but also improve.<\/p>\n<p>The lessons we learnt will benefit everyone in South Africa in the long term because more efficient processes mean that people won&#8217;t have to wait unnecessarily long for new medicines that come onto the market because of administrative wheels turning slowly.<\/p>\n<p>But our new processes also have wider benefits.<\/p>\n<p>Having strong regulatory systems in place is part of achieving universal health coverage, says the World Health Organisation (WHO), because it reduces the chance, especially in developing countries, that people will buy counterfeit, unsafe or ineffective medicines.<\/p>\n<p>Universal health coverage means that all people, regardless of how much they&#8217;re able to pay, get the health services they need. This type of coverage is part of the United Nations sustainable development goals, which 193 countries, including South Africa, have agreed to achieve by 2030.<\/p>\n<p>The plan with which South Africa aims to get universal health coverage is the National Health Insurance (NHI) scheme. Many details about the NHI still have to be decided on, and the NHI Bill has been widely criticised for gaps.<\/p>\n<p>One way to address at least some of these shortcomings is through Sahpra&#8217;s faster approval processes.<\/p>\n<p><b>Shaking up Sahpra\u2019s systems has paid off <\/b><\/p>\n<p>The WHO has a Global Benchmarking Tool that specifies what strict systems for overseeing the safety, efficacy and quality of health products should look like to help countries&#8217; medicines regulators improve. There are four maturity level ratings, ranging from a country having some elements of a control mechanism (level one) to the regulatory system being highly developed and improving all the time (level four).<\/p>\n<p>Shaking up our systems has already paid off.<\/p>\n<p>In October, the WHO awarded Sahpra\u2019s vaccine reviewing system level three maturity. This means that all the processes needed to ensure that people will get safe immunisations \u2014 from bookkeeping to ensuring quality production processes to overseeing the details of how clinical trials are run and keeping a record of side effects and what caused them \u2014 can be trusted to work well.<\/p>\n<p>Moreover, Sahpra&#8217;s systems for quality checking each lot of vaccines before it&#8217;s distributed is certified to work at level four standards. (A lot is a large batch of products all produced at the same time at a single facility.) A level four standard means Sahpra is operating at an advanced level and continuously improving its processes.<\/p>\n<p>This is good news for the mRNA vaccine technology transfer hub in Cape Town because it means people can have faith that the jabs developed there are up to international standards for use.<\/p>\n<p>The hub is a project the WHO set up in 2021 to help poorer countries to make their own vaccines.<\/p>\n<p>For other functions, for which Sahpra is currently graded at level three, we&#8217;re planning to reach level four maturity by 2025. That will put us on par with authorities listed as &#8220;stringent regulators&#8221;, such as those in the United States and the United Kingdom.<\/p>\n<p>Here&#8217;s how things used to be done \u2014 and how we&#8217;re speeding them up.<\/p>\n<p><b>How do medicines get approved? <\/b><\/p>\n<p>Medicines can be authorised for use in South Africa based on four types of approvals.<\/p>\n<p>Two evaluators work through all the data about the medicine gained during clinical trials. One person is the main reviewer, and their partner then double-checks the details of the application. If both assessors agree that there isn&#8217;t any further information needed from the manufacturer (for example, about quality, how the drug works compared with another, similar one or the production process), they pass the application on for quality control conducted by a different team. If the evaluation process reveals any queries that would need more discussion, the application gets passed on to a technical advisory committee.<\/p>\n<p>Once those issues have been addressed by the manufacturer, Sahpra will decide whether the medicine should be fully registered for use in South Africa or not.<\/p>\n<p>It works like this: If there&#8217;s enough evidence that a medicine or other health product is safe, works as it should and meets quality standards, Sahpra will allow the drug or product to be used by the public while the manufacturer waits for full approval. This can be helpful when research is still under way and the full data set that would usually have to be presented, is not yet available. It&#8217;s not a free pass, though: new, detailed information must be submitted within three months to a year, depending on the terms of the conditional approval.<\/p>\n<p>Doctors would normally have to apply for their patients to be treated with the medicine individually, but &#8220;bulk&#8221; approvals can also be granted when more than one patient needs the unregistered medicine.<\/p>\n<p>Instead of the process taking a year or more, as for full approvals, a Section 21 application can be processed in three days or less. The catch is that this type of approval lasts only for six months.<\/p>\n<p>Emergency use authorisation lasts only for six months.<\/p>\n<p>In the case of Covid vaccines, emergency authorisations helped to get lots of people vaccinated fast, because they could get a shot, such as Pfizer\/BioNTech\u2019s jab, Comirnaty, before it was granted full approval by Sahpra. (Cominarty got conditional approval only in January 2022, although by then, about 9 million people in South Africa had had two shots of that vaccine.)<\/p>\n<p>We learned three important lessons from implementing these types of approvals.<\/p>\n<p><b>Lesson 1: One meeting can be worth a thousand emails <\/b><\/p>\n<p>During Covid we set up a meeting with the drug manufacturer before they even started their application process.<\/p>\n<p>In this discussion, the pharmaceutical company could share what information they already had available, such as data from laboratory tests, initial safety or quality information or early results from clinical trials. They could then also ask us to clarify points in the application process they were unsure of. In turn, we could alert them to gaps in their data or extra information we would need.<\/p>\n<p>This significantly cuts down on the usual back and forth, because when the paperwork is eventually submitted, the regulator has had a heads-up about what\u2019s coming and the information the evaluators get to work with is prepared better. This means we\u2019ll have fewer questions for the applicant, and so the review can go quicker.<\/p>\n<p>We\u2019re planning on making these meetings an option for any application in the future.<\/p>\n<p><b>Lesson 2: Eat an elephant one bite at a time \u2014 rolling reviews help <\/b><\/p>\n<p>During the pandemic, a process called \u201crolling review\u201d, allowed Sahpra\u2019s team to analyse a product\u2019s data as it became available instead of having to wait for everything to be ready and then having to work through a massive amount of information all at once. Regulators in other countries had a similar system.<\/p>\n<p>It was used for the Johnson &amp; Johnson Covid vaccines used in South Africa, for instance. The manufacturer applied for registration, but submitted the supporting data to us in batches as it became available. Although clinical trials were still underway when the pharma company initially applied, getting some data earlier gave us a head start.<\/p>\n<p>Doing rolling reviews also halves the paperwork, because a company submits only one application for registration of their product, instead of putting in a Section 21 request first and then later going through another application round.<\/p>\n<p>Our Covid experience showed that rolling submissions can significantly reduce the time it takes to get medication to patients, especially when there\u2019s an urgent public health need. Faster access could help the NHI scheme to deliver universal health coverage.<\/p>\n<p><b>Lesson 3: Sharing is caring \u2014 especially in a health emergency <\/b><\/p>\n<p>Sahpra is part of a network of medicines regulators around the world. Being able to use \u201creliance mechanisms\u201d during the COVID pandemic helped us to do our own reviews faster. For example, when one of the internationally regarded trustworthy authorities \u2014 such as those classified as stringent regulators or others vetted by the WHO \u2014 has already approved a vaccine, we could use their analyses and reports to inform our decisions.<\/p>\n<p>The challenge with this approach, though, is to get other countries\u2019 regulators to share their reports without delay, which means that we have to maintain good relationships with such partners. In some cases, this strategy requires signing a memorandum of understanding or a non-disclosure agreement with a partnering regulator, as Sahpra has now set up with, among others, the US Food and Drug Administration (FDA). This means that we\u2019ll be able to use these regulators\u2019 reports and analyses for any product application that has already passed their desks \u2014 which can help us to get medicines to people faster.<\/p>\n<p>With these changes in place, we believe Sahpra can be a stronger partner for the NHI to ensure universal access to healthcare in South Africa.<\/p>\n<p>&#8211; Portia Nkambule is the chief regulatory officer of the South African Health Products Regulatory Authority. She\u2019s a pharmacist with a masters degree in public health.<\/p>\n<p><strong>For More News And Analysis About <a href=\"https:\/\/www.africa-press.net\/uganda\">Uganda<\/a> Follow <a href=\"https:\/\/www.africa-press.net\/\">Africa-Press<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Africa-Press &#8211; Uganda. During the Covid-19 pandemic, the South African Health Products Regulatory Authority (Sahpra) was forced to speed up its review of new medicines, such as vaccines, while still ensuring that they were safe and effective, writes Portia Nkambule. A leap year comes around every four years. As does the Olympics. And in the [&hellip;]<\/p>\n","protected":false},"author":84,"featured_media":39958,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,6],"tags":[233,240,234],"class_list":["post-39959","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all-news","category-files","tag-africa-press","tag-africa-press-uganda","tag-uganda"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.1 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ANALYSIS | 3 ways Covid sped up SA&#039;s medicine approvals process \u2014 and how it can help the NHI - Uganda<\/title>\n<meta name=\"description\" content=\"During the Covid-19 pandemic, the South African Health Products Regulatory Authority (Sahpra) was forced to speed up its ...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANALYSIS | 3 ways Covid sped up SA&#039;s medicine approvals process \u2014 and how it can help the NHI\" \/>\n<meta property=\"og:description\" content=\"During the Covid-19 pandemic, the South African Health Products Regulatory Authority (Sahpra) was forced to speed up its ...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi\" \/>\n<meta property=\"og:site_name\" content=\"Uganda\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/AfricaPressTunisiaa\" \/>\n<meta property=\"article:published_time\" content=\"2022-11-07T19:31:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-07T20:02:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/static.africa-press.net\/uganda\/sites\/34\/2022\/11\/postQueueImg_49-6369642859053.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1620\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"cfeditoren\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"cfeditoren\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi\"},\"author\":{\"name\":\"cfeditoren\",\"@id\":\"https:\/\/www.africa-press.net\/uganda\/#\/schema\/person\/068c7ab4e9634ae78ec5d54ec46598bb\"},\"headline\":\"ANALYSIS | 3 ways Covid sped up SA&#8217;s medicine approvals process \u2014 and how it can help the NHI\",\"datePublished\":\"2022-11-07T19:31:17+00:00\",\"dateModified\":\"2022-11-07T20:02:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi\"},\"wordCount\":1837,\"commentCount\":0,\"image\":{\"@id\":\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi#primaryimage\"},\"thumbnailUrl\":\"https:\/\/static.africa-press.net\/uganda\/sites\/34\/2022\/11\/postQueueImg_49-6369642859053.jpg\",\"keywords\":[\"Africa Press\",\"Africa Press-Uganda\",\"uganda\"],\"articleSection\":[\"all news\",\"files\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi\",\"url\":\"https:\/\/www.africa-press.net\/uganda\/all-news\/analysis-3-ways-covid-sped-up-sas-medicine-approvals-process-and-how-it-can-help-the-nhi\",\"name\":\"ANALYSIS | 3 ways Covid sped up SA's medicine approvals process \u2014 and how it can help the NHI - 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