巴西国内生产的活性药物成分:监管和战略框架
Marlon Daniel L Tonini1, Raquel O Lopes2, Maria Letícia C Barbosa3
1Marinha do Brasil, Hospital Naval Marcílio Dias (HNMD), Instituto de Pesquisas Biomédicas (IPB), Laboratório de Bioanálises, Rua Cesar Zama, 185, 20725-090 Rio de Janeiro, RJ, Brazil.
Anais da Academia Brasileira de Ciencias
|December 21, 2023
概括
巴西 巴西 巴西 巴西.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 药物开发 药物开发
- 卫生经济学 卫生经济学
背景情况:
- 全球活性制药原料 (API) 市场正在迅速扩张,预计将达到35594亿美元.
- 制药行业面临着COVID-19后的局面,需要重新评估生产和市场战略.
- 巴西是一个主要的制药消费者,严重依赖进口的API,在国内生产的仅为5%,造成健康脆弱性.
研究的目的:
- 批判性地分析巴西国家API生产和采购的当前监管和战略格局.
- 确定巴西尚未开发的API制造业的机遇和挑战.
- 为了解决巴西因依赖外国API进口而造成的健康脆弱性.
主要方法:
- 对巴西API制造的现有监管框架进行批判性分析.
- 战略评估国家产能和API生产潜力.
- 审查巴西的药品支出和进口依赖数据.
主要成果:
- 巴西的API制造业是不发达的,尽管国内制药支出很高,但依赖进口.
- 国内的API产量极低 (5%),对制药供应链安全构成风险.
- 需要大量投资来刺激巴西API制造能力的增长.
结论:
- 巴西为API制造提供了一个重要的,尚未开发的市场,这对国家制药生产和卫生安全至关重要.
- 解决国内API产量低的问题对于减轻健康脆弱性和加强国家制药业至关重要.
- 战略性监管方法和大量投资对于发展巴西的API制造业至关重要.
相关概念视频
Drug Control Governance: Regulatory Bodies and Their Impact
161
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
161
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
Preclinical Development: Overview
4.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.4K
Biopharmaceutics and Pharmacokinetics: Overview
2.0K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
2.0K
Bioequivalence: Overview
1.0K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.0K
Clinical Trials: Overview
3.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.0K


