Trends for 2023 in the pharmaceutical industry and Prespack’s further development plans

The pharmaceutical industry is one of many that will have to face changes in the coming year, stemming from new legal regulations (e.g., for medical devices) and market factors. So what transformations await the industry in 2023?

Outsourcing services in the pharmaceutical industry

Delegating parts of production processes to external companies has been common practice in the pharmaceutical sector for many years. However, outsourcing continues to expand into new areas year after year, a trend that is set to develop further. Pharmaceutical companies very frequently outsource contract packaging, enabling them to reduce costs in areas such as logistics, warehousing, labeling, and serialization and aggregation. Such practices bring numerous benefits, which are increasingly appreciated by manufacturers of medicines and medical devices, including:

• Lowering operational costs
• Reducing expenses associated with hiring specialists
• Transferring batch certification responsibilities to the packaging company

Outsourcing is an optimal solution for companies focused on growth that want to manage their projects efficiently. For many years, we have specialized in delivering dedicated contract packaging, serialization, and aggregation services for medicinal products, products containing psychotropic substances, and items requiring cold chain storage. We know how to optimize processes to ensure that outsourced services always maintain the highest quality.eczniczych, produktów zawierających substancje psychotropowe oraz innych wymagających przechowywania w tzw. zimnym łańcuchu. Wiemy, jak optymalizować procesy, by zlecane usługi były zawsze najwyższej jakości.

Digitalization of processes

This is another critical aspect for the industry. The optimization of manufacturing and packaging processes is achievable through the implementation of electronic records of production operations. This stems from the necessity of raising productivity and quality. Comprehensive knowledge of the currently running process and the ability to analyze it in real time have become extremely vital. The realization of these goals is enabled by designing and implementing an appropriate computerized system. At Prespack, we know that to adapt to market conditions and fulfill client requirements, as a company specializing in the contract packaging of medicinal products and psychotropic substances, we had to develop a system allowing for the automation of collecting and verifying production progress data. This is a challenge facing the entire industry to exercise even better control over the efficiency of provided services.

Regulatory changes – UDI

The revolution in the medical device market is ongoing. In 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) was adopted. The regulation was scheduled to take effect in 2020, but its application was postponed in the face of the coronavirus pandemic. The primary goal of the MDR is to establish a robust, transparent, and predictable regulatory framework for medical devices within the European Union. All devices are subject to UDI (Unique Device Identification) coding, with the exception of custom-made devices and those in the clinical investigation phase.

However, the legislator provided for transitional periods for the new regulations to mitigate the risk of shortages. On March 20, 2023, an amending regulation to the MDR was published in the Official Journal of the European Union, extending the transition periods for medical devices with certificates. The new deadlines depend on the risk class of the medical devices and ensure patients continuous access to these products. This will also allow medical devices placed on the market under previous regulatory frameworks to remain available without a rigid sell-off deadline.

What does the new regulation change? Certificates issued by notified bodies that were valid on May 26, 2021, and have not been withdrawn remain valid after the end of the period indicated in the certificate until December 31, 2027, for Class III and implantable Class IIb devices, and until December 31, 2028, for Class IIb, Class IIa, and Class Is and Im devices. Meanwhile, Class I devices under the MDD (Medical Device Directive) that, according to the MDR, should be classified into a higher class may be placed on the market until December 31, 2028, under certain specific conditions. Furthermore, the end date (sell-off clause) has been abandoned, meaning medical devices lawfully placed on the market before the MDR took effect can continue to be made available and put into service without a final cutoff date.

At Prespack, we constantly monitor changes in legal regulations. We make every effort to help our current and prospective clients implement them correctly, in compliance with the legal requirements of a given country.

Guarantee of safety – pharmaceutical serialization and aggregation services

Safety and full traceability are crucial factors. Pharmaceutical serialization and aggregation are two complementary processes that facilitate the realization of these objectives. Many companies that have completed the implementation of medicinal product serialization anticipate aggregation as their next step. It opens up new possibilities in tracking medications across the supply chain. Through the use of these solutions, pharmaceutical companies achieve significant savings. This is inherently linked with the modernization of the manufacturing process. Aggregation allows for radical time savings by eliminating the need to open every batch or master carton to find and scan an individual product. All data is readily available within the supply chain, making products easy to trace during every transaction. This positively impacts the efficiency of the distribution process and, consequently, the safety and reliability of operations. Analyzing trends and changes arising from our clients’ needs, our portfolio includes both serialization and pharmaceutical aggregation services, providing our partners with additional ways to safeguard their products.

A breakthrough investment at Prespack

In 2022, we continued construction work related to the establishment of Prespack’s new manufacturing site. It was a breakthrough year in this regard, as we officially signed the notary deed in November and accepted the building for operational use. Finishing works are underway, and hoping that everything goes according to the work schedule, we plan to launch contract manufacturing at the new location in the fourth quarter of this year. This will be a significant challenge, but the new manufacturing site will increase our production capacities and allow us to provide services at an even higher level. Much work and further challenges lie ahead, but we look to the future with optimism, counting on the continued growth of our operations.