China
Africa
Explore chapters and articles related to this topic
Rare Diseases Drug Development
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Shein-Chung Chow, Shutian Zhang, Wei Zhang
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Significant improvement may be demonstrated by the following: (i) evidence of increased effectiveness in treatment, prevention, or diagnosis of condition, (ii) elimination or substantial reduction of a treatment-limiting drug reaction, (iii) documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes, or (iv) evidence of safety and effectiveness in a new subpopulation.
Document Preparation
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
The principles underlying the preparation of these documents are the same as those to be discussed for licensing applications. Although the submission permitting clinical trials to begin is a regulatory requirement, it should be recalled that the submission is also the first impression the regulatory agency has of the drug. In the United States, at least, this impression can result in the drug being assigned priority review status. The preclinical summary thus becomes an extremely important document. Its preparation should receive the utmost care.
Neoliberalist approaches to healthcare and the transnational pharmaceutical corporations
Published in Théodore H MacDonald, Removing the Barriers to Global Health Equity, 2018
When new drugs are submitted to the US Food and Drug Administration (FDA) for marketing approval, the agency classifies them as meriting either ‘priority review’ (conferred for drugs that offer ‘major advances in treatment, or provide a treatment where no adequate therapy exists’) or ‘standard review’ (applied to a drug that offers ‘at most, only minor improvement over existing marketed therapies’). Only about one third of FDA approvals reach ‘priority.’
Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices
Published in Expert Review of Clinical Pharmacology, 2022
Tariro Sithole, Sam Salek, Gugu Mahlangu, Stuart Walker
The major difference in the review models between Zimbabwe and the other four countries is that the MCAZ requires a certificate of pharmaceutical product (CPP) – confirming that the medicine has been approved in the country of origin before it can be registered (Table 1). The MCAZ conducts a full review (type 3A) only for generics and biosimilars not approved by a reference authority but approved in the country of origin while the other agencies conduct a full review for all products. All of the studied agencies, with the exception of Health Canada, conduct abridged reviews while only the MCAZ and HSA conduct verification reviews. However, please note that a forward regulatory plan 2020– 2022 has been developed with an initiative title of ‘regulations amending the food and drug regulations – use of foreign decisions pathway,’ which will enable Health Canada to conduct abridged reviews of products approved by a trusted authority. (Table 1). The MCAZ currently uses verification review only for WHO- prequalified products while HSA conducts verification reviews for products approved by two reference authorities. All five agencies have a formal priority review procedure for medicines used in conditions for which no other treatment exists or for medicines improving existing therapies.
Ophthalmic Drug Discovery in the United States over the past Two Decades
Published in Ophthalmic Epidemiology, 2021
Approval applications were additionally classified by priority approval or standard approval. Of note, the Food and Drug Administration grants priority review to drugs that have the potential to “provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or preventions of a serious or life-threatening condition”, while standard approval is reserved for pharmaceuticals that do not demonstrate this potential.8(p.1) Individual drugs were additionally categorized by indication (e.g., ocular hypotensive agents, anti-VEGF therapy, anti-inflammatory agents). Given the relatively low number of approvals for ophthalmic indications over the entire study period, average rates of drug approvals and data analysis were performed by breaking the data into 5-year study period quartiles (2000–2004: 1st quartile, 2005–2009: 2nd quartile, 2010–2014: 3rd quartile, and 2014–2019: 4th quartile). Institutional review board approval was not required for this study as only publicly available data were used.
Impact of the biomarker enrichment strategy in drug development
Published in Expert Review of Molecular Diagnostics, 2020
Aline Bobato Lara Gongora, Leandro Jonata Carvalho Oliveira, Denis Leonardo Jardim
The FDA has developed special programs to speed the availability of drugs that treat serious diseases, especially when the drugs are the first available treatment for the disease or if it has advantages over existing treatments. Preferably, the companion test is developed concurrently with the therapeutic drug. This process is called co-development. When the diagnostic test and the drug are developed together, the pair goes to regulatory approval concurrently [23]. The FDA’s approaches to speed up the availability of drugs are Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track. The clinical development phase of drugs is constituted by the period from investigational New Drug [IND] submission to New Drug Application [NDA] submission. The approval phase is characterized by the period between NDA submission and FDA drug approval [24].