[일간보사 발췌]
미국 FDA가 21세기의 기술발전에 발맞춰 제품개발 평가를 위한 규제과학 개혁 전략을 공개했다.
FDA는 소비자 보호를 위해 전임상 효과·안전성 검토에서 판매후 조사에 이르기까지 규제활동에 가능한 최신 과학을 적용하는 것이 중심적인 책임이라며 이같이 밝혔다.
이번 계획에는 세포치료, 조직공학, 유전체학, 개인맞춤 치료, 컴퓨터 및 정보기술 등의 분야에서 신제품 및 신물질을 개발·평가하는 절차를 협력적으로 개선시키기 위한 방안이 담겨져 있다.
아울러 최근 커뮤니케이션 기술이 급속히 발달하면서 정보취득 방식을 변화시킴에 따라 소비자 건강정보 커뮤니케이션 개선책 연구도 강조됐다. 또한 다양한 파트너와의 협력도 중시됐다.
특히 필수적 규제과학 우선순위 분야로는 독성학의 현대화, 개인맞춤 치료 및 임상평가 혁신촉진, 신속한 신기술 평가, 정보과학을 통한 다양한 데이터 활용, 새로운 예방적 식품 안전 시스템 시행, 소비자와 전문가의 정보적인 결정을 위한 사회 및 행동과학 강화 등을 꼽았다.
또한 제품 제조 및 품질 개선을 위한 지원으로서 약품 품질에 대한 연속 및 일괄 제조방식의 영향을 이해하기 위해 조사할 계획이며, 제품 실패율에 영향을 주는 제조기술도 조사하기로 했다.
그리고 제품의 안전성·효과·품질에 대한 부형제 및 복합 배합의 역할을 평가하고, 프로세스 분석기술과 디자인 품질 등 최신 제조기술의 품질 일관성 유지능력에 대한 영향을 밝히는데도 집중할 방침이다.
이밖에도 FDA는 제품 품질 평가를 위한 분석적 기법을 개발하고 미생물 오염을 감지하기 위한 검사도 만들기로 결정했다.
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김자연 기자 (nature@bosa.co.kr)
[FDA 홈페이지 발췌]
http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm
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Strategic Plan for Regulatory Science
Advancing Regulatory Science at FDA: A Strategic Plan (August 2011)
The Food and Drug Administration (FDA) protects and promotes the health and safety of all Americans through enhancing the availability of safe medical products and foods and promoting innovation that addresses unmet medical and public health needs. FDA also protects and promotes the health and safety of animals through assuring the availability of safe animal drug products and food. FDA is a science-based regulatory agency and a critical component to the success of the nation’s public health, health care systems, and economy. FDA was created in 1906 as one of our nation’s principal consumer product protection agencies, and is now responsible for assuring the safety of biologics, such as blood products and vaccines, drugs, medical devices, foods, cosmetics, and many other consumer goods. Since 2009, it has also been responsible for regulating the manufacture, marketing, and distribution of tobacco products. In the U.S., FDA-regulated products account for about 25 cents of every dollar spent by American consumers each year ? products that touch the lives of every American every day. FDA is responsible for advancing the public health by helping to speed innovations that make foods safer and make medicines and devices safer and more effective. At the same time, FDA helps consumers and health care providers get the accurate and science-based information they need to make the best possible decisions about their use of medical products and foods for human and non-human animal use. FDA must make decisions based on the best available scientific data and using the best tools and methods available in order to ensure products meet the highest quality standards for consumers, while at the same time fostering and advancing innovation in the products it regulates.
The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities ? from pre-market review of efficacy and safety to post-market product surveillance to review of product quality. In the last few years, rapid advances in innovative science have provided new technologies to discover, manufacture and assess novel medical products, and to improve food safety and quality; FDA must both keep pace with and utilize these new scientific advances in order to accomplish its mission to protect and promote the health of our nation.
FDA’s Strategic Plan for Regulatory Science
To meet this need, FDA has developed a strategic plan for regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. This plan identifies eight priority areas of regulatory science where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission. The priority areas are:
- Modernize Toxicology to Enhance Product Safety
- Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
- Support New Approaches to Improve Product Manufacturing and Quality
- Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
- Harness Diverse Data through Information Sciences to Improve Health Outcomes
- Implement a New Prevention-Focused Food Safety System to Protect Public Health
- Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
- Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products
FDA will apply available resources to implement the Strategic Plan for Regulatory Science through management of scientific programs within FDA and engagement of collaborators and partners in industry, academia and government. FDA’s Strategic Plan for Regulatory Science is designed to allow the Agency both to meet today’s public and animal health needs and to be fully prepared for the challenges and opportunities of tomorrow to help harness revolutions in science that can be translated into products that help make and keep our nation both safe and healthy.
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