Biologicals are pharmaceutical products used in healthcare research, diagnosis and prevention for treatment of diseases. These are collected from live cells or tissues such as sera, vaccine, recombinant products, etc. Basic biologicals such as cells, tissues, serums, blood, and sputum samples are used for potential therapeutic, diagnostics and research applications.
Medical and healthcare research on animals and humans involve the import of biologicals, which needs to comply with certain regulations. Maintaining the safety and efficacy of such products is vital. Regulatory bodies have mandated their prior approval to analyze the quality of imported products. It also keeps a check on the sale and trade of these biological research materials as bio-terrorism is a growing threat to every country today.
Import of Animal Biologicals
Animal biologicals such as animal blood, animal plasma, animal serum, and animal tissues are obtained from a wide variety of species, including animal products. These are collected from larger animals that are anti-parasite and antibiotic. Bio-product collection is also requested from smaller animals from controlled colonies. Trade of veterinary biologicals internationally has always been restricted to certain factors such as:
- Concerns that the imported animal biological could introduce foreign diseases into the country of import.
- Import decisions as directed by regulatory authorities like the North American Free Trade Agreement (NAFTA) and World Trade Organization (WTO) must be science-based and transparent. In this context, regulatory organizations must weigh the credibility, validity, and risk-based analysis models prior to decision making.
Import of Human Biologicals
Though the human biological material is no longer a part of a living body, yet individual claims of ownership of these products can raise ethical questions. Today, human biological specimens such as human serum, human whole blood, etc are stored in a bio-repository known as the bio-bank. The need for harmonization of multiple standard procedures for lab practices is necessary as there is no one regulatory practice in place. Import of biological materials requires permission from the authority; however, new rules have eased the import and export of such samples. This will only fasten the transfer process to recipient countries.
New Rules to Relax Import Policies
Research centers and biotech companies can relax as the government has now decided to bring changes in the stringent import policies. It will initiate a hassle-free and time saving way to import and export biological samples. As per the new mandate, the research organization must file a self-certification with the customs authority. It includes a necessary declaration that the applicant organization will follow all the procedures for safe transfer and disposal of biological samples. Only after complying with the import regulations concerning biological research materials can the regulatory body allows the transfer of these products for further research.
Research Bodies Welcome Move
Research experts understand the value of time saving biological transfer of materials such as animal serum, animal plasma, human blood, and more. Biotechnological research organizations are excited about the move brought about by international regulatory bodies. Moreover, these research companies are concerned about complying with the self-certification procedure to get benefited from the new relaxed rules for the import of biologicals. This will not only reduce time spent in sending applications, but will also save money and manpower required with follow-up procurements and obtaining approvals.
Learn more about Innovative Research and our high quality research materials including human, plant, and animal biological, ELISA & Assay Kits, proteins, antibodies, cell cultures, blood, serum, plasma, and more. More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.