When it comes to new medicines and other pharma products there is a genuine necessity to ensure the safeguarding of the product before it hits the market. A Post-Authorisation Safety Study (PASS) has a system that has been designed with just that in mind. Here, we will take a look at how PASS works within the pharma sector, and how companies with the logistical knowledge to get new pharma products to market within all the safety parameters provide an essential service to those pharma companies developing new medicines the world over.
What exactly is PASS?
A post-authorisation safety study, PASS is designed to provide an extensive study into the safety of the medicine in question. A benefit-risk profile is created, providing a transparency about the product and the safety of it before it can be put forward in front of the regulatory process for making a decision on its release into the market.
A PASS must identify any safety hazards that are present or potentially present within the medicine. It must also be used to quantify and fully describe those safety hazards. Only once this safety profile has been extensively put together can the regulatory process take place. It allows for a thorough process to measuring the effectiveness of the protocols to manage the potential risk of any safety hazards linked to each product. With this information as a basis, measures and protocols can be developed or improved upon should this be a necessity.
With any product there will either be a PASS conducted through non-interventional studies or through clinical trials. There are strict protocols in place for the assessment of imposed PASSs, as well as templated to follow for non-interventional studies. It is all designed with the safety of the medicine in mind and as thorough a process as possible taking place before a product can be signed off as ready for the market.
With the correct support, a product can be brought to market through a transparent and streamlined process where every stage is passed with a great big tick. Every single medicine must go through extensive clinical research, a development process, inspection of the medicine, audits, and PASS before passing through the regulatory decision-making process. Without any of this there is no guarantee of the effectiveness or safety of a product.
Looking for information about how to get a new medicine to market has never been easier. Enlisting the assistance of a company with the experience and tools to get new pharma products to market is an essential part of any pharma strategy. This ensures that there is the right level of specialist support to work within strict health and safety parameters and to pass the strict clinical trials regulations that are set within the EU currently. There are many logistical challenges along the way when it comes to delivering a new product to market in pharma, so finding the right type of specialist support is a key factor in the success of a new medicine.