A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

Ndomondo-Sigonda, Margareth; Mahlangu, Gugu; Agama-Anyetei, Margaret; Cooke, Emer

doi:10.1371/journal.pmed.1003099

Cited by 13 publications

(18 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The nucleic acid and subunit vaccines are already considered inherently safer than those depending on attenuated virus particles ( https://www.niaid.nih.gov/research/vaccine-types ). The distributed approach described here will need greater regulatory harmonisation between countries [ 70 , 71 ]. The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the current resource for global harmonisation activities, quality, safety and efficacy guidelines and standards.…”

Section: Downstream Of Synthetic Biologymentioning

confidence: 99%

“…The distributed approach described here will need greater regulatory harmonisation between countries [70,71]. The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the current resource for global harmonisation activities, quality, safety and efficacy guidelines and standards.…”

Section: Box 4 Responsive Regulationmentioning

confidence: 99%

See 1 more Smart Citation

Build a Sustainable Vaccines Industry with Synthetic Biology

Kitney

Bell²,

Philp

2021

Trends in Biotechnology

View full text Add to dashboard Cite

The vaccines industry has not changed appreciably in decades regarding technology, and has struggled to remain viable, with large companies withdrawing from production. Meanwhile, there has been no let-up in outbreaks of viral disease, at a time when the biopharmaceuticals industry is discussing downsizing. The distributed manufacturing model aligns well with this, and the advent of synthetic biology promises much in terms of vaccine design. Biofoundries separate design from manufacturing, a hallmark of modern engineering. Once designed in a biofoundry, digital code can be transferred to a small-scale manufacturing facility close to the point of care, rather than physically transferring cold-chain-dependent vaccine. Thus, biofoundries and distributed manufacturing have the potential to open up a new era of biomanufacturing, one based on digital biology and information systems. This seems a better model for tackling future outbreaks and pandemics. The Vaccine Production Model Needs to ChangeThe COVID-19 crisis has cast the vaccines industry into scrutiny [1]; an industry that has been silently beleaguered for decades (https://www.who.int/immunization/programmes_systems/ procurement/mi4a/platform/module2/2019_Global_Vaccine_Market_Report.pdf?ua=1). A United States National Academy of Sciences study from 2003 [2] concluded that the amount that the nation spent on vaccines 'appears to be insignificant compared with that spent on other medical and social interventions that may have lesser social benefits.' Large company numbers that supply vaccines have steadily reduced [3]: some 80% of vaccines arise from five multinationals (https://www.who.int/immunization/programmes_systems/procurement/market/ global_supply/en/). At the heart of the problem is a tension between relatively poor financial returns to the vaccine industry and the high costs in production and R&D [4].Compared to small molecule pharmaceuticals, centralised vaccine production facilities are capital intensive [5]. Fixed costs are high [6], especially for new vaccines. For example, the need for eggs for production is at least 70 years old, is expensive and time-consuming, but difficult to replace [7]. In past high-income countries have paid a higher price until the fixed costs are amortised. Then lower-income countries have adopted vaccines as the price has dropped after paying the fixed costs. However, there is now tremendous pressure for a COVID-19 vaccine to be available for all who need it, effectively everyone. Distributed Manufacturing, a More-Sustainable Vaccine ModelThe long distribution chains of centralised vaccine production are patchy, resulting in incomplete geographical coverage [8] (Box 1). Even if there is no overall shortage, there may be where they are needed most. Centralisation of labour and production has been the norm in many industries, but in 2015 the World Economic Forum (WEF, see Glossary) put distributed manufacturing in its top ten emerging technologies for the year (https://www.weforum.org/agenda/2015/03/top- HighlightsBiofoun...

show abstract

Section: Downstream Of Synthetic Biologymentioning

confidence: 99%

Section: Box 4 Responsive Regulationmentioning

confidence: 99%

Build a Sustainable Vaccines Industry with Synthetic Biology

Kitney

Bell²,

Philp

2021

Trends in Biotechnology

View full text Add to dashboard Cite

show abstract

“…The EU's system is only one of many regulatory harmonization initiatives from around the world [14]. A number of new initiatives have emerged recently inside Africa [1], and many prominent initiatives exist outside Africa as well (Table 2). In our work with these and other initiatives, a few best practices have emerged that are consistent with the maxim "simplify, streamline, and standardize."…”

Section: Best Practices From Other Initiatives Around the Worldmentioning

confidence: 99%

“…In the final article in this Special Collection in PLOS Medicine about the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative [1][2][3][4], we, a group of authors who have had no involvement in the EAC MRH's work to date, provide an independent perspective on the program's work thus far and its plans for the future. The initiative's goal is to improve access to essential medicines in East Africa by simplifying the process of registering medicines and increasing the speed at which registration applications are reviewed while ensuring that only high-quality medicines are approved.…”

mentioning

confidence: 99%

“…Dr Grignolo then invited us to contribute, as a team of coauthors with rich and varied experience in regulatory harmonization. We were provided with drafts of the other articles in the Special Collection [1][2][3][4], but otherwise, this perspective was written without input or influence from the other authors or from the EAC MRH initiative or its partners, including the Bill & Melinda Gates Foundation. Information about each author's background can be found in S1 Text.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Giaquinto¹,

Grignolo

Liberti

et al. 2020

PLoS Med

View full text Add to dashboard Cite

• The goal of improving access to quality medicines in East Africa has been addressed by the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative, which is working to simplify the process of registering medicines and increase the speed at which registration applications are reviewed while ensuring that only highquality medicines are approved. • This article was written by a group of authors with varied expertise in global regulatory affairs but no involvement to date in the EAC MRH initiative. The authors were asked to provide an independent perspective on the initiative's work since its launch in 2012, as well as its plans for the future.

show abstract

The African Medicines Agency and Medicines Regulation: Progress, challenges, and recommendations

Abdulwahab,

Okafor,

Adesuyi

et al. 2024

Health Care Science

View full text Add to dashboard Cite

BackgroundIn response to the situation of the African healthcare system, the African Medicines Agency (AMA) was established by the African Union (AU) to regulate access to medicines and support the local manufacture of medications. This study aimed to describe the factors that enabled the establishment of the AMA and its successes, challenges, and perceived benefits.MethodWe reviewed data sources that explored the progress and challenges of the African Medicines Agency and Medicines Regulation in Africa. The SPIDER framework was used to organize the research focus and to extract the keywords for the literature search. The study data were obtained from PubMed Central, ScienceDirect, and Google Scholar.ResultOut of 249 studies screened, 19 were selected for this narrative review. Critical successes observed in the agency's establishment include the appointment of a Special Envoy, the selection of its headquarters, and the signing of its treaty by 37 member states. However, it is hindered by poor political commitment, differences in risk‐benefits interpretation and organizational structure, weak legal and regulatory frameworks, inadequate financial mechanisms, and inadequate political and policy leadership in some member states.ConclusionThe value of AMA in achieving optimal health outcomes and its other benefits must be considered despite the challenges being encountered. Therefore, all member states should adopt the best procedures in signing and ratifying the treaty and implementing associated commitments to improve efficiency and accountability in African medicine regulation.

show abstract

A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

Cited by 13 publications

References 12 publications

Build a Sustainable Vaccines Industry with Synthetic Biology

Build a Sustainable Vaccines Industry with Synthetic Biology

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

The African Medicines Agency and Medicines Regulation: Progress, challenges, and recommendations

Contact Info

Product

Resources

About