Sector Committee Spotlight: European Standards Medicines Sector Committee

Interviewer: Today, we are pleased to feature the European Standards Medicines (ESM) Sector Committee of EuroCham Vietnam, a group that has been instrumental in advancing the use of high-quality generics and biosimilars in Vietnam. Thank you for joining us. Let’s start with some recent updates: we’ve known you as IQMED for some time, and we understand you have rebranded to European Standards Medicines (ESM). Could you tell us more about this change?

ESM Chairman Gregory Charitonos: The decision to change our name from IQMED to European Standards Medicines (ESM) reflects our commitment to more accurately represent the interests of companies operating in Vietnam that adhere to the high standards of drug quality and safety set by the European Union. This rebranding signifies a broader focus on advocating for the recognition and integration of EU pharmaceutical standards in Vietnam, ensuring that the medicines produced and distributed by companies meet the rigorous criteria established in the EU.

With this new identity, European Standards Medicines (ESM) will place greater emphasis on advocating for quality, safety, and efficacy in pharmaceuticals, especially for European companies working in Vietnam.

Interviewer: Will this new identity influence your mission moving forward?

ESM Chairman Gregory Charitonos: Our mission has always been to improve access to high-quality, affordable medicines in Vietnam, particularly focusing on generics and biosimilars. We work closely with both European and Vietnamese stakeholders to ensure these medicines meet the stringent safety, efficacy, and quality standards required. Ultimately, our goal is to enhance healthcare outcomes for Vietnamese patients by increasing access to cost-effective treatment options.

With our rebranding to ESM, the committee’s refined mission includes:

– Supporting companies in navigating Vietnam’s regulatory environment while maintaining compliance with EU standards.

– Advocating for regulatory alignment between Vietnam and the EU to create an environment where high-quality medicines are accessible to Vietnamese patients.

– Emphasizing our core values of collaboration, transparency, and regulatory excellence in our interactions with stakeholders in both Europe and Vietnam.

Interviewer: Could you share some of the key achievements of the sector committee in recent years?

ESM Chairman Gregory Charitonos: We have achieved several milestones over the past few years. One of our most significant accomplishments has been in regulatory alignment. We have worked diligently to bring Vietnam’s pharmaceutical regulations closer to EU standards, easing market entry for European generics and biosimilars.

We have actively contributed to the draft amendments of the Pharma Law and have been following up closely until its expected ratification. Additionally, we provided comments and recommendations to the Drug Administration of Vietnam under the Ministry of Health on the amendment of Circular 08/2022/TT-BYT.

Last year, we successfully organized a two-day Scientific Workshop held in Hanoi, featuring a keynote speech from Mr. Nguyen Thanh Lam, Deputy Head of DAV. The workshop brought together hundreds of evaluators, professors, and experts from Vietnam, the UK, Poland, and other countries to share their knowledge and experiences in the pharmaceutical field.

Interviewer: That’s impressive! What current projects is the committee working on?

ESM Chairman Gregory Charitonos: We’re currently focused on our Clinical and Bio-equivalence Program. This initiative aims to provide professionals in Ho Chi Minh City and Hanoi with deeper insights into the evaluation process. To support this, we are organizing workshops and seminars to engage healthcare providers and ensure they are well-informed about our programs.

Interviewer: It sounds like the committee is addressing some important challenges. What obstacles have you encountered, and how are you tackling them?

ESM Chairman Gregory Charitonos: One of our main challenges is regulatory harmonization. While progress has been made, aligning Vietnamese regulations with EU standards still presents some hurdles. We maintain continuous dialogue with regulatory authorities to streamline approval processes for high-quality generics and biosimilars.

However, the growing demand for affordable healthcare solutions in Vietnam also presents a significant opportunity. As the healthcare sector expands, there is a rising need for cost-effective medicines such as generics and biosimilars. This aligns with our mission to make high-quality healthcare more accessible to Vietnamese patients.

Interviewer: With the rebranding, will there be any changes to the membership process or benefits?

ESM Chairman Gregory Charitonos: There will be no changes to the membership process or benefits for our current members. ESM will continue to provide valuable resources, networking opportunities, and advocacy support. The rebranding aims to strengthen the committee’s advocacy efforts in Vietnam, potentially leading to greater engagement with local regulatory bodies and more collaboration opportunities for companies committed to high standards in pharmaceuticals. Members may also benefit from increased visibility and recognition through ESM’s advocacy efforts.

Interviewer: Are there any new initiatives or important events that ESM will be hosting soon?

ESM Chairman Gregory Charitonos: Following our transition to European Standards Medicines, we are planning to launch several new initiatives to support European pharmaceutical companies in Vietnam. These initiatives will include workshops and training sessions focused on navigating Vietnamese regulations while ensuring compliance with EU standards. These events will offer a platform for sharing best practices, discussing regulatory challenges, and fostering collaboration to raise pharmaceutical standards in the region.

Interested in joining European Standards Medicines Sector Committee? Kindly contact SC Coordinator Hanh Nguyen at ngochanh.nguyen@eurochamvn.org.

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Marieke Van Der PIJL

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