Susan Haigney

Concept of EMA European Medicines Agency. Drugs evaluation and quality control department. | Image Credit: ©wladimir1804 -stock.adobe.com

On Dec. 19, 2025, Emer Cooke, executive director of the European Medicines Agency (EMA), published highlights of the agency’s accomplishments in 2025, which marked three decades since its inception. Among EMA’s successes was the recommendation of 104 new drugs during the year, with almost 40% containing a new active substance (1).

Chief among the 2025 events, according to Cooke, is the 

 between the European Commission (EC), the European Parliament, and the Council of the European Union to revamp pharmaceutical legislation (2), 

How will EMA shift to address new legislation?

“The agreement on the new pharmaceutical legislation is a historic milestone for medicines regulation in Europe and for patients across the EU, a golden opportunity to become more agile and efficient,” Cooke stated in the release (1).

Cooke said the agency will be using the opportunity provided by the legislation to focus efforts in three areas. The agency will be “reimagining” how it works, and Cooke plans to adapt systems to better handle scientific and technological advancements. Early development and innovation will be supported to enable quicker market authorizations. Investments will also be made in staff and network workforce to build capacity and capabilities.

What drug recommendations were made by EMA?

EMA recommended 104 new drugs in 2025, 40% of which were new active substances. These included the first treatment to delay the onset of stage 3 type 1 diabetes in adults and children aged eight and older. The first treatment for Duchenne muscular dystrophy was also recommended for patients aged six and older who can walk. Europe also got its first Chikungunya vaccine for adolescents aged 12 and older.

EMA also recommended changes to the use of the antibiotic azithromycin to reduce the chance of antimicrobial resistance. Plus, measures were recommended to minimize the risk of suicide with finasteride and dutasteride, which is used to treat androgenetic alopecia in men.

 in January to provide a coordinated system and framework for how the agency works with national authorities and actors in the European Union to ensure that the supply chain of drugs is robust.

The agency coordinated with the European Commission and other regulatory bodies to communicate across channels and worked with content creators to promote safe and responsible use of GLP-1 drugs. “In an environment where misinformation spreads faster than facts, we must embrace innovative approaches to communication and stakeholder engagement,” Cooke stated.

“Europe has always been a place where ideas spark change. It has world-class science and world-class expertise. We need to protect and promote these strengths,” she continued. “We need a Europe where facts matter, innovation thrives, and collaboration wins. The future is ours to shape—let’s shape it together, with science.”

EMA. Emer Cooke, EMA’s Executive Director: 2025 Achievements in Medicine Regulation. Press Release. Dec. 19, 2025. 

https://www.ema.europa.eu/en/news/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation

European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation

EMA. EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation

Articles

In 2025, the European Medicines Agency (EMA) celebrated its 30th anniversary by recommending 104 new drugs, with 40% featuring new active substances. A significant milestone was the agreement to revamp EU pharmaceutical legislation, enhancing EMA's agility and efficiency. The agency plans to focus on reimagining operations, supporting early development, and investing in workforce capabilities. Notable drug recommendations included treatments for type 1 diabetes, Duchenne muscular dystrophy, and a Chikungunya vaccine. EMA also launched the European Shortages Monitoring Platform to strengthen drug supply chains and collaborated to promote responsible drug use.

Executive Director Emer Cooke presents EMA’s achievements for the year.

EMA Director Sees Legislation Revamp as Highlight of 2025

Ask the Expert: Training for a Skilled Workforce

Geopolitical stressors, such as trade policies put in place by the Trump administration in the United States, have pushed some pharmaceutical companies to invest in moving production and building new facilities in the US (1). With expansion, however, comes the need for qualified personnel to run operations in these manufacturing facilities.

But the industry has been struggling in recent years in obtaining the personnel with the proper skill sets to meet demand. And because pharmaceutical development and manufacturing are regulated industries, training personnel is crucial to ensure safe and effective medicines reach the patients that need them. So how can pharma companies ensure their staff, new and current, are up to speed on the latest tools, processes, and regulations?

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt, PhD, VP Technical at Parexel, delve into the complexity of training in this episode of Ask the Expert.

“I think the question on training is really fascinating, says Schniepp. “We do keep hearing there is a shortage of workers for these facilities. I think there's going to need to be a lot of training fast to bring workers up to date and up to speed to man these new facilities. And I think the whole concept of training has changed from internal, where we did it internally with our little PowerPoint slides and somebody watching to more virtual training has undergone in the last 2030, years, massive changes, and we use AI tools.”

“We need to talk about delivery [of training],” Schmitt stresses. “There are many more ways to deliver these days than we had 1020, years ago. You and I, we've been a while in this industry, but certainly we find that almost every day we learn something new, we hear something new, we had no idea about something interesting comes about. So, learning doesn't stop. And the other thing that I certainly look back to when, when I started in industry and I needed to learn all the basics, it was learning by watching, by being told by the people who have been in the industry for a while. So, it's not so much in the first instance about reading the books or reading the standard operating procedure, reading the instruction. It's a lot about learning from those who've done it before. So there needs to be a mix, I'd say. You can't just throw out instructions and give it to people and say, ‘here you read and you understand and you sign off’. You still need some experienced workforce that holds your hand and that guides you through what needs to be done.”

Click the video above to watch Sue and Siegfried answer the following question:

“My company is building new manufacturing facilities in the US, which will require additional workforce and skill sets. What kind of training is required and how can we deliver that training?”

Cole, C. How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains. 

https://www.pharmtech.com/view/how-100-pharmaceutical-tariffs-will-impact-domestic-manufacturing-and-supply-chains

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs company

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt, PhD, VP Technical at Parexel

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets. 


Europa medicada | Image Credit: ©Parato -stock.adobe.com


 (EMA) positively responded to the news that the European Commission (EC), the European Parliament, and the Council of the European Union have reached an agreement to comprehensively reform pharmaceutical legislation in the EU (1). The 

 to move forward with a 2023 proposal by the European Commission was announced on Dec. 11, 2025 (2). The reform will grant regulatory data and market protection for a period of eight years with additional years given to drugs developed for unmet needs and other considerations.

According to EMA, with this reform, the development and authorization of drugs will be modernized and procedures will be simplified. Current regulations that will be impacted will include Regulation 726/2004 and Directive 2001/83/EC, Regulation 1901/2006 and Regulation 141/2000/EC (medicines for children and rare diseases, respectively), and the advanced therapy medicinal products (ATMP) Regulation 1394/2007.

“Today marks a historic milestone for European medicines regulation and for patients across the EU,” said EMA’s Executive Director Emer Cooke in a press release (1). “The revamp of the pharmaceutical legislation will enable EMA and the European medicines regulatory agencies network to become more agile and efficient while upholding the highest standards of scientific rigor.”

“By simplifying procedures, embracing digitalization, and rationalizing our use of scientific resources, we will be better positioned to support innovation and ensure that promising new treatments reach patients faster,” Cooke added in the release (1). “The new legislation also provides us with the tools to deliver on our network strategy to 2028 and address the major public health challenges of the future, from antimicrobial resistance to emerging health threats.”

How will the reform impact EMA procedures?

The agency’s committee structure will be made leaner and will be complemented by increased patient and healthcare professional representation. This includes the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee.

Assessment times will be reduced from 210 days to 180 days, freeing up scientific resources for pre-authorization support for drug companies. Digital solutions will include the requirement for drug applicants to submit market authorization applications in electronic formats and provide product information in electronic form.

Possibly one of the most interesting changes is that market authorization of a drug will be valid by default for an unlimited period. The agency states this will avoid unnecessary administrative burden surrounding renewals, unless required for safety reasons determined by EMA’s scientific committees.

How will these changes improve innovation?

The agency states that. with these reforms, it will be able to offer extended scientific advice with health technology assessment bodies and strengthen support for drugs under priority medicine designation. EMA will also be able to request that the EC establish a regulatory sandbox to test requirements for innovative medicines that cannot be developed under the current rules.

Adapted frameworks may also be created for certain non-standard drug categories, and process inefficiency improvements for pediatric medications can be established, such as the formalization of a new process from iterative pediatric investigation plans.

The agreement is subject to formal approval by the European Parliament and the Council and may take months to years to be finalized. During that time, EMA will work with the EC and EU Member States to develop guidance documents to help drug developers comply with the new rules. EMA will be keeping stakeholders informed as the process goes forward and has plans for an information repository web page available for pharmaceutical companies.

EMA. EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

The European Medicines Agency (EMA) has endorsed a significant reform of EU pharmaceutical legislation, agreed upon by the European Commission, European Parliament, and the Council of the European Union. This reform aims to modernize drug development and authorization, streamline procedures, and enhance innovation. Key changes include extended regulatory data protection, reduced assessment times, and digitalization of application processes. The reform also introduces unlimited market authorization validity, unless safety concerns arise. Formal approval is pending, and EMA will collaborate with stakeholders to ensure compliance with the new regulations.

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union. 

EMA Calls New EU Pharma Legislation Most Significant in Two Decades

European Union Health Concept | Image Credit: ©xtock -stock.adobe.com

On Dec. 11, 2025, the European Parliament 

 that it has reached an agreement with Council negotiators to move ahead with revising the pharmaceutical policy framework in the European Union (1), following a proposal in 2023 by the 

 (EC) to revise pharmaceutical legislations to adapt to patient and industry needs to make drugs more accessible and affordable (2). The reform addresses the issues of market protection, antimicrobial resistance (AMR), market authorization, and drug availability. The Council is expected to formally adopt the agreement and Parliament is expected to endorse the agreement in 

“We need new, innovative therapies for unmet medical needs, for conditions currently without treatment, rare diseases, pediatric medicines, new antibiotics,” 

 (EPP, PL), Chair of the Committee on Public Health (SANT), said in a press release (3). “We need equal access to medicines in all Member States, without delays, as differences in access between EU Member States can now reach up to two and more years. But equally importantly, we need medicines we can afford, meaning that competition of cheaper medicines begins immediately after an agreed deadline that protects innovation. I believe that for all these purposes, we have managed to achieve a balance in the regulations of this largest reform of the EU medicines market in over 20 years.”

What does this mean for market exclusivity?

As part of the reform, there will be a regulatory data and market protection period of eight years. During this time, other companies cannot access product data. An additional year will also be granted of market protection following market authorization in which generic or biosimilar products cannot be sold.

In addition, another year of market protection will be granted for the following drug types:

medicines that contain a new active substance that fulfill “a combination of conditions on comparative clinical trials, clinical trials carried out in several member states, and the obligation to apply for market authorization within 90 days after the submission of the application for the first marketing authorization outside the Union” (1)

medicines that provide one or more new therapeutic indications that have a significant benefit compared to products already on the market.

Under the agreement, the combined regulatory protection period will have a cap of 11 years. Drugs for orphan diseases with no current treatment available would get up to 11 years of exclusivity.

“To support earlier market entry of generic and biosimilar medicinal products, the deal clarifies the scope of the ‘Bolar’ exemption (which allows manufacturers to conduct certain activities during the market protection period of the original product). Patent rights would not be infringed when necessary studies, trials and other activities are conducted for the purposes of obtaining marketing authorizations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications,” the press release clarifies (1).

How will antimicrobial resistance be improved?

The deal introduces a ‘transferable data exclusivity voucher’ for priority antimicrobials. This voucher will give AMR drugs a year of additional data protection for one authorized product. The extension may only be used once for the priority drug or for another authorized drug of the same or different marketing authorization holder.

Stricter requirements, such as compulsory medical prescriptions, specific information in package leaflets, and an awareness card for package leaflets that are only available online will be put into place as part of the agreement. Companies will also need to provide an antimicrobial stewardship plan and a risk evaluation for AMR as part of a mandatory environmental risk assessment.

The European Medicines Agency (EMA) will have their internal functioning simplified as part of the updated rules, with marketing authorization applications submitted electronically in a common format and drug approvals valid by default for an unlimited period. Regulatory sandboxes to allow for development and testing of innovative drugs may be set up by the EC under supervision of competent authorities.

EC. European Health Union: Commission Proposes Pharmaceuticals Reform for More Accessible, Affordable, and Innovative Medicines. Press Release. April 25, 2023. 

https://ec.europa.eu/commission/presscorner/detail/en/ip_23_1843

European Parliament. Deal on EU Pharmaceutical Package–Statements. Dec. 11, 2025. https://www.europarl.europa.eu/news/en/press-room/20251209IPR32112/deal-on-eu-pharmaceutical-package-statements

The European Parliament and Council have agreed to revise the EU pharmaceutical policy framework, aiming to enhance drug accessibility and affordability. The reform addresses market protection, antimicrobial resistance, and drug availability, with a focus on innovative therapies for unmet medical needs. Market exclusivity will be capped at 11 years, with specific provisions for orphan drugs and priority antimicrobials. The European Medicines Agency will streamline its processes, including electronic submissions and regulatory sandboxes for innovative drug development. The agreement awaits formal adoption by the Council and endorsement by Parliament.

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

European Parliament Revamps Pharmaceutical Policy Framework

Drug manufacturing process. Conveyor with medical tablets blisters line at modern pharmaceutical plant. Pharmacology production, medicine industry. Laboratory, factory, pharmacy. Healthcare, pharma 3D | Image Credit: ©Corona Boreal -stock.adobe.com

Contract packaging organization, Tjoapack, 

 that it is expanding its packaging services and operational footprint in the United States. A new 170,000-sq.-ft. facility will be built next to the company’s existing site in Clinton, Tenn. The new facility, scheduled to be completed in early 2027, will include a good manufacturing practice suite with packaging, labeling, cold chain, and ambient storage capabilities.

The expansion will support high-speed packaging lines for a variety of dosage forms, such as solid dosage bottles and blister packs, vials and autoinjectors for injectable products, and secondary packaging.

“This expansion marks a major step in our strategic goal to enhance our presence in the United States. As a crucial market with considerable growth opportunities, it allows us to serve our existing clients more effectively and attract new ones.” said Dexter Tjoa, CEO of Tjoapack, in a press release (1). “We’ve invested heavily in automating our core processes, not only within packaging lines but throughout our cross-company workflows with customers and material vendors. This allows us to reduce human error and enhance accuracy, speed, and flexibility, which ultimately benefits our clients.”

What other expansions has the company invested in?

 it was expanding cold chain storage services in both the US and The Netherlands for injectables and biologics (2). The company’s Etten-Leur site in The Netherlands added 84 pallet spaces, and its Clinton, Tenn. facility completed installation of two advanced packaging lines. The site added a high-speed, full automated vial packaging line with an annual processing capability of 20 million vials. Cold storage capacity was also expanded at the site with a total of 160 good manufacturing practice-compliant pallet spaces controlled at 2–8 °C.

What will Tjoapack be showcasing at Pharmapack Europe 2026?

 with be showcasing its packaging solutions at the 

 event in Paris on January 21–22 at Paris Expo Porte de Versailles. The team will be at Stand 4D118 to talk about the company’s capabilities in oral solid dosage packaging, vials and prefilled syringes, primary packaging, secondary packaging, biotech packaging, and unit dose packaging.

What are some recent innovations in pharma packaging?

® in March 2025 to discuss innovations in bio/pharmaceutical packaging, such as those that have resulted from the demand for temperature-sensitive therapies and customized packaging configurations (3).

“We've been investing heavily in expanding our cold chain capabilities, in expanding our capability and capacity to package unique configuration for injectable products, whether that is a product that comes to us in a syringe format, a vial format, or an auto injector format,” Belden said in the interview. “[We have] the ability to either automate or semi-automate, label, and then finish [to] pack those products while maintaining tight control of time [and] temperature to allow for packaging, and then getting those materials and finished goods back into cold storage. [We also serve] as a potential logistics hub for several of our clients to manage the supply complexity, then shipping those time- and temperature-sensitive medicines to the many markets around the world that our client base is serving.”

Sustainability has also been impacting the choices made for packaging materials, as companies work to meet environmental standards. 

, vice-president, Climate and Circular Economy, 

 before her presentation at CPHI Frankfurt 2025 in October about fiber-based packaging and how it can help pharmaceutical companies meet their sustainability goals (4).

“By definition, fiber-based packaging means packaging that is made of paper or paper board. Paper and paper board is made from pulp, and the typical raw material for pulp is wood,” Pohjakallio explains.

According to Pohjakallio, the wood must be sourced from sustainable sources. For example, all the wood procured by Metsä Group and Metsä Board comes from either certified forests or forests that meet the requirements of controlled origin. The procured wood is also utilized in a sustainable way, she explains. For instance, logs from the thickest part of the trees are utilized for making mechanical wood products, and wood from the thinner parts of the trees that don't qualify for timber and construction elements are used for making pulp.

Tjoapack. Tjoapack Announces Major US Expansion to Improve its Packaging and Logistics Capabilities. Press Release. Dec. 5, 2025. 

https://www.tjoapack.com/news-events/tjoapack-announces-major-us-expansion-to-improve-its-packaging-and-logistics-capabilities

Tjoapack. Tjoapack Continues to Expand Its Global Infrastructure with Strategic Investments in Injectable Packaging and Cold Chain Capabilities. Press Release. June 5, 2025.

Haigney, S. DCAT Week 2025: Packaging Innovations. 

https://www.pharmtech.com/view/dcat-week-2025-packaging-innovations

Haigney, S. CPHI Frankfurt 2025: Fiber-Based Packaging for Sustainability. 

https://www.pharmtech.com/view/cphi-frankfurt-2025-fiber-based-packaging-for-sustainability

Tjoapack is expanding its US operations with a new 170,000-sq.-ft. facility in Clinton, Tenn., set to open in 2027. This expansion will enhance packaging services, including high-speed lines for various dosage forms and cold chain capabilities. The company has also invested in cold chain storage in the US and The Netherlands. Tjoapack will showcase its packaging solutions at Pharmapack Europe 2026. Innovations in pharma packaging focus on temperature-sensitive therapies and sustainability, with fiber-based packaging emerging as a key solution for meeting environmental standards.

A new facility in Tennessee will boost high-speed pharma packaging capacity and strengthen US supply chain support.

Tjoapack’s Advanced Packaging Expansion Aims to Meet  Rising Demand

Sanner, a company that offers sustainable packaging products and contract development and manufacturing services, announced on Dec. 10, 2025 that it will be showcasing its new Tethered Cap as part of its sustainable effervescent tablet packaging portfolio at 

, which is being held from Jan. 21–22 in Paris.

Because the TE safety ring on the tethered cap stays attached, it allows for all plastic components to be recycled, which has become a priority for manufacturers of effervescent supplement tablets looking to improve sustainability of their products. The Tethered Cap also is easy to implement to existing filling processes without changeovers or interruptions.

“Supporting a functioning circular economy is very important to Sanner,” emphasized Stefan Verheyden, CEO of the Sanner Group, in a press release (1). “This applies to our products as well as our own operations. The fact that we recently achieved EcoVadis Gold status confirms that sustainable processes are firmly anchored in our corporate strategy.”

Sanner will be presenting the Tethered Cap along with its expanded global production footprint and packaging services, including its portfolio of desiccant solutions, such as the TabTecCR, for moisture- and odor-sensitive pharmaceuticals and supplements, at booth 4G46 during the event.

In addition, Verheyden and Jim Collins, president of Pharmaceutical Delivery Systems LLC, will provide insights into the impact of international trade policy on the pharmaceutical industry in their joint presentation at the event on Jan. 21, 2026, at 11 a.m.

How are sustainability efforts impacting pharma?

Early efforts in sustainability in pharma have become foundational to the industry in recent years and are a strategic focus dictated by evolving client expectations, rigorous environmental audits, and respecting planetary boundaries (2, 3). This industry shift is a response to global climate pressures—the healthcare sector contributes 4.4% of global carbon emissions—and a recognition that profitability and responsibility must converge (3–5).

At CHPI Frankfurt, Maija Pohjakallio, VP, Climate and Circular Economy, Metsä Group, discussed how fiber-based packaging can help with sustainability efforts.

“A very important question related to packaging is that by optimizing your packaging solutions, you can reduce your scope three emissions,” Pohjakallio said in 

 (3). “And regarding fiber-based packaging, there are two very important elements that actually have a big influence on the carbon footprint on the packaging. One is the share of fossil free energy utilized in the production. And the other one is material efficiency. If you use less fibers in making the packaging of same properties, of course, that means better carbon footprint.”

, which is headquartered in Germany, has manufacturing facilities across Germany, France, Hungary, China, and the United States. The company offers desiccant closures and effervescent tablet packaging, customized solutions in the areas of medical devices and diagnostics, pharmaceuticals, and consumer healthcare, and supplies its products to more than 150 countries globally and has more than 820 employees.

“Sanner has consistently expanded both its global presence in device development and its production capacities over the past two years,” explained Christian Classen, CSO of the Sanner Group, in the press release (1). “By providing the entire process—from design to verification and validation to commercial production—from a single source, customers benefit from consistent Design for Manufacturing and Assembly right from the early development phase. With the help of the expertise of our Human Factors specialists, we can also optimize usability. This integrated approach enables a seamless transition from development to industrialization and has been proven to reduce complexity, development times, and project risks."

For more coverage of Pharmapack Europe, visit 

Pharmapack 2026: Sanner launches Tethered Cap

Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

CPHI Frankfurt 2025: Fiber-Based Packaging for Sustainability

Working Together to Improve the Environment

Sanner is set to showcase its new Tethered Cap at Pharmapack Europe, emphasizing sustainability in effervescent tablet packaging. The cap's design allows for complete recycling of plastic components, aligning with the industry's sustainability goals. Sanner's CEO highlights the company's commitment to a circular economy, supported by their EcoVadis Gold status. The company will also present its global production capabilities and desiccant solutions. Additionally, Sanner's leaders will discuss international trade policy impacts on the pharmaceutical industry. The shift towards sustainability in pharma is driven by client expectations and environmental audits.

The new Tethered Cap, which will be showcased at 2026 Pharmapack Europe, addresses the demand for sustainability with a TE safety ring that remains attached to the cap.