scholarly journals South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

2021 ◽  
Vol 12 ◽  
Author(s):  
Andrea Keyter ◽  
Sam Salek ◽  
Lorraine Danks ◽  
Portia Nkambule ◽  
Boitumelo Semete-Makokotlela ◽  
...  
Keyword(s):  
South African ◽  
Regulatory Authority ◽  
Generic Product ◽  
Regulatory Review ◽  
Regulatory Pathways ◽  
Market Authorization ◽  
New Chemical Entities ◽  
Good Review ◽  
Generic Products ◽  
Business As Usual

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices that have been implemented by SAHPRA to support the assessment of new chemical entities and generic product applications for market authorization in the business-as-usual and backlog process streams.Methods: A questionnaire was completed and verified by SAHPRA to describe the structure of the organization, the resources available, the process for regulatory review of new chemical entities and generic products and the level of implementation of good review practices and regulatory decision-making practices for market authorization. Data were collected and analyzed on the overall approval timelines for new chemical entities and generic products registered by SAHPRA in 2020 in the business-as-usual and backlog process streams.Results: A full, independent scientific review was conducted for all new chemical entities and generic product applications in the business-as-usual stream. Facilitated regulatory pathways were introduced for the review of new chemical entities and generic products in the backlog stream. As a result, the timelines for approval of applications in the backlog stream were 68% quicker for both new chemical entities and generics, using facilitated regulatory pathways, such as abridged and verification review models.Conclusion: The comparisons made through this study provided insight into the improvements that have been made through the establishment of SAHPRA and the transition in 2018 from the MCC. The re-engineered processes that have been developed and implemented by SAHPRA to address the backlog in the review of the applications for market authorization have demonstrated a decrease in the overall median approval times. The expansion of these processes into the routine review of medical products will contribute to the enhanced regulatory performance of SAHPRA and patients’ access to new medicines.

scholarly journals A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency

2020 ◽  
Author(s):  
Andrea Keyter ◽  
Sam Salek ◽  
Shabir Banoo ◽  
Stuart Walker
Keyword(s):  
South African ◽  
Regulatory Authority ◽  
The South ◽  
Regulatory Review ◽  
Regulatory Systems ◽  
African Health ◽  
Health Products ◽  
Review Model ◽  
South African Health ◽  
Regulatory Performance

Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new regulatory review model for improved regulatory performance, underpinned by the parameters of the World Health Organization Global Benchmarking Tool (WHO GBT) that support strengthening of regulatory systems. Methods: A new enhanced model for regulatory review, was developed based on the key recommendations from 6 studies, previously conducted by the authors, that were identified as fundamental elements in enhancing regulatory performance. The elements selected to define the new regulatory review model were endorsed through the integration of the parameters of the WHO GBT that, when embedded within regulatory systems, support enhanced regulatory performance. Results: Opportunities for improvement in regulatory performance were identified and include quality measures; monitoring and evaluating review times; a risk-based evaluation; transparency and communication; and training and education. An improved model for the South African regulatory review and benefit-risk (BR) assessment supported by quality decision-making was proposed as well as recommendations for the application of risk-stratification strategies, strengthening of reliance networks, reinforcing good regulatory practices (GRPs) and enhancing transparency. Conclusion: If implemented the proposed improved regulatory model may pave the way towards more efficient and transparent, streamlined review processes, coupled with increased consistency, evidence-based decision-making practices, reduced timelines and improved patients’ access to new medicines in South Africa.

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies

2019 ◽  
Vol 143 (1) ◽  
pp. 73-77
Author(s):  
Anat Gafter-Gvili ◽  
Ariadna Tibau ◽  
Pia Raanani ◽  
Daniel Shepshelovich
Keyword(s):  
Hematological Malignancies ◽  
New Drugs ◽  
Priority Review ◽  
Regulatory Review ◽  
Regulatory Pathways ◽  
The Us ◽  
Black Box Warnings ◽  
Accelerated Approval ◽  
Drug Approvals ◽  
Approved Drugs

The prevalence of safety-related postmarketing label modifications of medications for hematological malignancies is unknown. We identified 35 new drugs indicated for hematological malignancies approved by the US Food and Drug Administration between January 1999 and December 2014. Characteristics of supporting trials and safety-related label modifications from approval to December 2017 were collected from drug labels. Regulatory review and approval pathways were also collected. New drug approvals were supported by trials with a median of 167 patients (interquartile range 115–316). All drugs were approved based on surrogate endpoints. Twenty-seven drug approvals (77%) were not supported by randomized controlled trials. All drugs received orphan drug designation, and most were granted fast track designation, priority review, and accelerated approval (83, 74, and 60%, respectively). A total of 28 drugs (80%) had postmarketing safety-related label modifications. Additions to black box warnings, contraindications, warnings and precautions, and common adverse reactions were identified in 31, 11, 77, and 46% of drugs, respectively. Five drugs (14%) were permanently or temporarily withdrawn from the US market. Drugs for hematological malignancies are often approved based on limited evidence through expedited regulatory pathways with incomplete safety profiles. Hematologists should be vigilant for unrecognized side effects when prescribing newly approved drugs.

Comparative study of different meloxicam generic products with the brand product

2019 ◽  
pp. 116-124
Keyword(s):  
Immediate Release ◽  
Generic Product ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Innovator Product ◽  
Similarity Factor ◽  
Generic Products ◽  
Brand Product

This study aims to evaluate different products of meloxicam Table; Five meloxicam immediate-release generic products (15 mg Tables) were compared with the innovator, reference product, (Mobic®, Boehringer) to find the interchangeable product with the innovator product. Different physical tests were conducted including weight uniformity, thickness, diameter, hardness, friability and disintegration test. In addition, prediction of in-vivo behavior was assessed by measuring the dissolution profile of meloxicam for all the products. Similarity factor (f2) was calculated to compare between the dissolution profile of the generic products with the dissolution profile of innovator product. The results revealed that all the studied products are complied with the British Pharmacopoeia requirements. However, not all of them showed similar in-vitro profile to the brand product. Four out of five generic products, included in this study, showed similarity in dissolution profile to the brand one, which indicates possible bio-equivalency, with the advantages of money saving of using such generic products. One generic product showed similarity factor less than 50, which might give an indication that this generic product is not capable to be bioequivalent with the brand (innovator) product. Overall, this study can be considered an important applicable study that gives an indication about the in-vivo performance of different products. In addition, the study demonstrates the applicability of a simple in-vitro dissolution study as a surrogate way of assessing product bioavailability instead of an expensive and complicated in-vivo bioequivalent study.

scholarly journals Suppression of Emergence of Resistance in Pathogenic Bacteria: Keeping Our Powder Dry, Part 2

2015 ◽  
Vol 60 (3) ◽  
pp. 1194-1201 ◽  
Author(s):  
G. L. Drusano ◽  
William Hope ◽  
Alasdair MacGowan ◽  
Arnold Louie
Keyword(s):  
Pathogenic Bacteria ◽  
Bacterial Resistance ◽  
Multidrug Resistant ◽  
New Drugs ◽  
Resistant Bacteria ◽  
Regulatory Review ◽  
Content Type ◽  
Drug Resistant Bacteria ◽  
Antibiotic Drug ◽  
New Chemical Entities

We are in a crisis of bacterial resistance. For economic reasons, most pharmaceutical companies are abandoning antimicrobial discovery efforts, while, in health care itself, infection control and antibiotic stewardship programs have generally failed to prevent the spread of drug-resistant bacteria. At this point, what can be done? The first step has been taken. Governments and international bodies have declared there is a worldwide crisis in antibiotic drug resistance. As discovery efforts begin anew, what more can be done to protect newly developing agents and improve the use of new drugs to suppress resistance emergence? A neglected path has been the use of recent knowledge regarding antibiotic dosing as single agents and in combination to minimize resistance emergence, while also providing sufficient early bacterial kill. In this review, we look at the data for resistance suppression. Approaches include increasing the intensity of therapy to suppress resistant subpopulations; developing concepts of clinical breakpoints to include issues surrounding suppression of resistance; and paying attention to the duration of therapy, which is another important issue for resistance suppression. New understanding of optimizing combination therapy is of interest for difficult-to-treat pathogens likePseudomonas aeruginosa,Acinetobacterspp., and multidrug-resistant (MDR)Enterobacteriaceae. These lessons need to be applied to our old drugs as well to preserve them and to be put into national and international antibiotic resistance strategies. As importantly, from a regulatory perspective, new chemical entities should have a resistance suppression plan at the time of regulatory review. In this way, we can make the best of our current situation and improve future prospects.

scholarly journals The Corona Virus and Migration Governance in South Africa: Business As Usual?

2020 ◽  
Vol 55 (1) ◽  
pp. 100-112 ◽  
Author(s):  
Franzisca Luise Zanker ◽  
Khangelani Moyo
Keyword(s):  
South Africa ◽  
South African ◽  
Asylum Seekers ◽  
The Political ◽  
The South ◽  
Ongoing Research ◽  
Border Fence ◽  
The Government ◽  
And Migration ◽  
Business As Usual

The South African response in dealing with the Corona pandemic needs to speak to the realities of all people living in the country, including migrant and refugee communities. Reflecting on this in light of ongoing research on the political stakes of migration governance, we find that the virus response shows little change in the government agenda when it comes to dealing with refugees and other migrants. Veritably, we see that the pandemic may even be an excuse for pushing through already-aspired to policies. This includes the securitised agenda behind the sudden building of a border fence to close off Zimbabwe and the xenophobic-rhetorical clout behind the lockdown rules about which shops are allowed to remain open. The temporary stay on renewing asylum seekers permits counts as a perfunctory exception. We show that each of these developments very much play into politics as usual.

Policy Punctuations and Regulatory Drug Review

2003 ◽  
Vol 15 (2) ◽  
pp. 157-191 ◽  
Author(s):  
Stephen J. Ceccoli
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review ◽  
Review Time ◽  
University Center ◽  
The Past ◽  
Percent Increase ◽  
New Chemical Entities ◽  
Drug Review

The FDA has dramatically decreased the regulatory review time for new drugs since the early 1990s. For example, according to the Tufts University Center for the Study of Drug Development (CSDD), which conducts triennial analyses of new drug approvals in the United States, the average FDA review time for approved New Chemical Entities (NCEs) decreased from 35.6 months in 1984–86 to 16.8 months in 1996–98. Thus, in a little more than a decade, the FDA has essentially cut its average review time in half. In addition to the declining review times, the agency's workload, as measured in terms of the number of drugs approved each year, also rose considerably in the 1990s. Specifically, the agency approved a total of 232 NCEs between 1993 and 1999, compared to just 163 approvals during the previous seven-year span—a 42 percent increase. Figures 1 and 2 illustrate the agency's decreased review times and increased workload, respectively. Thus, over the past decade the FDA has approved more drugs and done so in less time than at any other period in history. Simply stated, this change in regulatory performance, especially the declining review times, has been absolutely stunning.

scholarly journals FDA's drug regulatory pathways, its development strategies and regulatory considerations

2021 ◽  
Vol 9 (2) ◽  
pp. 6-15
Author(s):  
Iva Dhulia ◽  
Himani Patel ◽  
Narendra Chauhan ◽  
Nidhi Pardeshi
Keyword(s):  
Prescription Drugs ◽  
Active Ingredient ◽  
Drug Product ◽  
The United States ◽  
Development Strategies ◽  
New Drugs ◽  
Regulatory Pathways ◽  
New Drug ◽  
Generic Products ◽  
Abbreviated New Drug Applications

People who are interested in drug development may be aware that New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are 2 of the FDA's regulatory pathways for how prescription drugs can be approved and ultimately reach the market. In basic terms, NDAs are for new drugs that have not yet been approved and ANDAs are for generic products. NDA, also called 505 (b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. Under 505(b)(1), all investigations supporting safety and effectiveness, both clinical and nonclinical, are conducted by or on behalf of the sponsor. The other pathway is termed as abbreviated because preclinical and clinical trials are not required. The abbreviated approval pathways are described in section 505(j) and 505(b)(2) of the FD&C Act and known as ANDA and Hybrid applications respectively. Hatch-Waxman amendments in 1984 provided for a suitability petition that allows the application of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient). The differences allowed for suitability petition and 505(b)(2) application are same but ANDA filed through suitability petition can contain only those differences that do not need clinical evidence for efficacy and safety. This article identifies considerations to help potential applicants determine the appropriate submission pathway, its development strategies to support approval under those pathways.

Product Associated Variation in Generic Enoxaparin. Potential Clinical Implications

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1249-1249
Author(s):  
Jawed Fareed ◽  
Debra Hoppensteadt ◽  
Albara Ottman ◽  
Omer Iqbal ◽  
Walter Jeske ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Conflicts Of Interest ◽  
Generic Product ◽  
Clinical Implications ◽  
Similar Distribution ◽  
Thrombin Time ◽  
Distribution Profile ◽  
Molecular Weight Range ◽  
Safety And Efficacy ◽  
Generic Products

Abstract Abstract 1249 Recently the generic versions of enoxaparin brand (Sanofi-Aventis) have widely become available. Since enoxaparin is a biological product, minor compositional changes in these agents may potentially have clinical implications. Generic enoxaparins are manufactured by several companies and marketed under specific trade names. The purpose of this investigation was to determine the differences between generic products and within product variations in the same generic product. Eight generic products from India (Cutenox, Markaparin, Clenox, Lomoparin, Lupenox, Lomorin-NX, Lomoh-40 and Troynoxa-40), four generic products from South America (Enoxalow, Versa, Heptron and Endocris), and one generic product from the USA (Enoxaparin sodium) were studied. The molecular weight profile of generic products showed relatively similar distribution profile with a molecular weight range of 3.9–4.9 kDa. The anti-FXa activity ranged from 87–110 U/mg, whereas wider variations were noted in anti-FIIa activity (28–41 U/mg). The anti-FXa:anti-FIIa ratio ranged from 3.1–4.2. Much wider variations (up to 60%) were noted in the anticoagulant assays (ACT, aPTT, Heptest, and thrombin time). Additionally the generic products also showed variations in the thrombin generation assay. Protamine and PF4 titration profile also showed variations. AT mediated inhibition of thrombin and FXa in the biochemical assays showed wider differences in IC50 values. Heparinase digestion profile showed variable oligosaccharide composition and some of the products contained heparinase resistant glycosaminoglycans. A comparison of 5 batches of the branded enoxaparin (Clexane) and 5 batches of a generic enoxaparin showed that the generic product batches exhibited greater variation in the biologic assays despite a comparable anti-FXa profile. These observations suggest that despite the current regulatory requirements, product based differences in the generic enoxaparins exist, which may impact their safety and efficacy profile in cardiovascular and thrombotic indications for which the branded enoxaparin is approved. Additional pharmacodynamic studies and clinical validations of the safety and efficacy of each of the generic products maybe helpful in assuring a clinical equivalence of the generic products with the branded enoxaparin. Disclosures: No relevant conflicts of interest to declare.

scholarly journals The South African Election of 2009

2009 ◽  
Vol 44 (2) ◽  
pp. 111-124 ◽  
Author(s):  
Roger Southall ◽  
John Daniel
Keyword(s):  
South African ◽  
African National Congress ◽  
General Election ◽  
The South ◽  
South Africans ◽  
Provincial Level ◽  
The People ◽  
National Congress ◽  
Business As Usual

South Africans voted in their country's fourth democratic general election on 22 April 2009. The African National Congress (ANC) again secured a substantial victory. It might seem that the 2009 Elections proved to be “business as usual”. Yet such a conclusion is unjustified, for events had conspired to generate excitement about this particular contest, which rivalled that leading up to the “liberation election” of 1994. The reasons for this were several, but the most important revolved around Jacob Zuma, who had risen to the presidency of the ANC in December 2007, and the formation of a new party of opposition, the Congress of the People (COPE), by dissidents from within the ANC. In the elections, however, the ANC reasserted its dominance. Even so, the results of the 2009 election at national and provincial level indicate change. The ANC has maintained its electoral dominance, yet its grip on the electorate has been somewhat weakened, while the opposition – although remaining very much in the minority – has consolidated.

scholarly journals To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e028677 ◽  
Author(s):  
Thomas Christian Kühler ◽  
Magda Bujar ◽  
Neil McAuslane ◽  
Lawrence Liberti
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
European Medicines Agency ◽  
Regulatory Pathways ◽  
Time Period ◽  
The Us ◽  
New Chemical Entities ◽  
Assessment Guidelines ◽  
Available Information ◽  
Active Substances

ObjectiveTo compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016.DesignUsing publicly available information from FDA and EMA websites, new active substances (NASs) approved by each agency from 2014 to 2016 were identified and their characteristics assessed. Divergences in regulatory outcomes for simultaneous (within 91 days) submissions to both agencies were identified and then examined for use of facilitated regulatory pathways and orphan designations; submitted versus approved indications; and approval times.ResultsIn 2014–2016, 115 NASs were approved by EMA or FDA or both; 74/115 were new chemical entities and 41 new biological/biotechnology entities; 82/115 were approved by both agencies, 24 only by FDA and nine only by EMA. Simultaneous submission occurred for 52/115; 13/52 received expedited review by both agencies and 18 only by FDA; 8/52 received conditional approval from both agencies, 2/52 only from FDA and 1/52 only from EMA; 17/52 were designated as orphans by both agencies and 10/52 by FDA only; 31/52 indications were approved as submitted and 21 changed by EMA and 29/46 were approved as submitted (six not assessed) and 17/46 changed by FDA. Median FDA review timelines were 319 days compared with 409 days for EMA.ConclusionsThere was general agreement in EMA / FDA conditional approvals. FDA used expedited pathways and orphan designation more often than EMA, suggesting stricter EMA criteria or definitions for these designations or less flexible processes. Despite consistency in submitted indications, there was lack of concordance in approved indications, which should be further investigated. FDA review times are faster because of a wider range of expedited pathways and the two-step EMA process; this may change with recent revisions to EMA accelerated assessment guidelines and the launch of Priority Medicines.

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