Who issue license for manufacturing a distribution of drugs and pharmaceuticals?
Answers from top 3 papers
More filters
Papers (3) | Insight |
---|---|
28 Citations | Yet this particular place provides an entry point for exploring how the location of the scientific knowledge component of pharmaceuticals – rather than their production, licensing, or distribution – matters. |
Findings – The paper builds the business case for radio frequency identification (RFID) technology to be employed to track pharmaceuticals in the supply chain and counter the growing threat of counterfeit drugs. | |
10 Citations | In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. |
Related Questions
How are pharmaceutical Scientists regulated ACTs for different countries?5 answersPharmaceutical scientists are regulated through various Acts in different countries to ensure compliance with regulatory requirements. These Acts govern the approval processes for marketing and distributing pharmaceutical products, focusing on safety, efficacy, and quality standards. For instance, in India, pharmaceutical regulations are crucial for both domestically produced and imported products, covering aspects from innovation to post-marketing studies. International law evasion has been a significant issue in the pharmaceutical industry, emphasizing the need for legal-pluralist approaches combining state, regional, and international regulations with self-regulation and activism to control corporate crime. The development of drug regulations and the pharmaceutical industry has been influenced by historical events like vaccine tragedies and thalidomide incidents, leading to the establishment of Acts mandating pre-marketing approval and marketing authorization processes in countries like the USA and Europe.
What are the regulations of the pharmaceutical industry?4 answersThe pharmaceutical industry is highly regulated to ensure the safety, efficacy, and quality of drug products. Regulatory authorities impose rules and regulations to protect public health and well-being. The approval for marketing and distributing pharmaceutical products in regulated markets is governed by guidelines such as "marketing approval," "registration," "marketing authorization," or "product licensing". Common Technical Document (CTD) and electronic Common Technical Document are used as standardized formats for the approval process in Europe, the United States, Japan, and other countries with minor variations. Regulatory bodies like the Food and Drug Administration (FDA) in the United States collaborate with other agencies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to provide guidelines for harmonizing testing requirements and approval processes. Pharmaceutical analysis is crucial to verify drug product quality.
What are the advantages of licensing for the firm?5 answersLicensing offers several advantages for firms. Firstly, licensing agreements can help firms to cut through the patent thicket and prevent hold-up problems. Secondly, licensing allows firms to avoid high investments in Research and Development. Thirdly, licensing can enhance the value of the innovator's own product in a market with network effects. Fourthly, licensing can mitigate the intensity of price competition and is beneficial for the innovating firm. Lastly, licensing provides firms with access to new knowledge creation opportunities, especially for firms that have experienced early-stage innovation failures. These advantages make licensing a valuable strategy for firms in various industries.
How do I get a drug distribution license in India?5 answers
How to set up a pharmaceutical distribution company?7 answers
How to start drug distribution business in India?4 answers