It is easy to understand why the US Food and Drug Administration feel the need to oversee inspections of foreign drug facilities. A high percentage of drugs available in the US are manufactured overseas, and the safety of these products must be assured. How does this FDA intervention help prevent the availability of dangerous drugs?
When a product is not made on home soil, additional checks must be carried out to make sure that finished drugs and pharmaceutical ingredients are complying with the correct rules and regulations. Of course, the same must be done for drugs made within the country, but due to differing codes of practice overseas, the need for further checks is greater. Not only must the drugs be safe, but the product labels must meet certain requirements to be acceptable.
What is being done?
The FDA has increased the number of routine inspections performed on facilities abroad. This means carrying out extra safety procedures in addition to taking samples and running tests to ensure a high quality level of any products that are due to be distributed within the country. The FDA also shares information with foreign regulatory bodies to ensure that any complications are well known.
One way to safeguard the proposal of new products to the market is the FDA 510k clearance submission. Device manufacturers must provide the FDA with at least 90 days’ notice of their intention to market a medical device. There are many rules regarding this premarket notification, and they can be found on the FDA’s website. The main focus is for manufacturers to demonstrate that their product is safe, effective and does the same job at a minimum of similar products currently available. If you want to apply for a product to be FDA cleared, tprg can point you in the right direction.
Safeguarding the manufacture and distribution of drugs within the country is an extremely important process to ensure the safety and quality of products. Foreign countries are relied on to produce these drugs, and with careful monitoring and clear lines of communication established with foreign regulatory bodies, the FDA can try to prevent any unsafe products from arriving in the country. With the increase in inspections of overseas facilities, the FDA will do its utmost to keep foreign-made drugs safe and effective.