New rules for outsourcing in the pharmaceutical industry: many possibilities!
Recently, ANVISA surprised everyone when they published the new rules for outsourcing in the pharmaceutical industry by publishing RDC 234/18 bringing innovations in established concepts such as the need for quality control to be carried out in the laboratory by the importer himself.
The main changes of RDC 234 in relation to 25/2007 are:
· Removes the obligation to notify the outsourcing contract to ANVISA,
· It passes the responsibility for outsourcing exclusively to the contracting company and determines that the contracted company is jointly and severally liable.
· Starts to accept that the quality control is outsourced
· In cases of outsourcing of production stages and quality control analyzes, the registration and post-registration legislation must be complied with.
· It now allows subcontracting by 3rd party companies, as long as the contractor authorizes it.
· It opens the possibility that storage in the 3rd may occur even in quarantine if there is a validated quality system that communicates between companies.
Analyzing with a little more depth it is noted that the new outsourcing rules are not so surprising as they are in line with ANVISA's guidelines to empower the companies that have the registration on their respective products in line with what is being done with post-registrations.
234/18 makes it clear that it is the Contractor's duty to provide the Contractor with the necessary information for outsourcing to be carried out in accordance with the drug registration, to audit and qualify the contractor, as well as to be responsible for the release of the final product. Even in the controversial issue of total outsourcing of quality control, it is noted that ANVISA did not give up the repetition of quality control in Brazil, but rather aligned with international rules, since this model is accepted in highly regulated surveillance countries.
At this first moment, some companies may be feeling harmed for having made investments that are no longer needed, however, in the medium term, they may also benefit because, even the national ones, usually have some imported product in their portfolio or, eventually, they have the need to outsource testing.
In addition, a window of opportunity opens for new companies and products that may not reach Brazilian patients to enter the country. From now on, a range of new possibilities starts, to cut costs without necessarily giving up quality.