Chinese pharmaceutical companies are facing a growing demand for domestic and international products. However, as they seek to enter highly regulated markets like the EU and US, they encounter unique challenges. 

Challenges and Requirements for Chinese Pharmaceutical Companies in EU and US Markets

Chinese Pharmaceutical companies may encounter before registering their medicinal products in the EU and US markets:

  • Focus on China market

Clinical trials performed only include Chinese patients, so an EU licensing partner may be required to conduct additional trials. As there is no EU setup in place, there may be a lack of understanding of EU regulations. The company may be unsure about where to start in terms of market entry. There is also no Good Manufacturing Practice (GMP) certification in place.

  • Planned for international markets

Clinical studies are requirements for both US and EU registrations. No additional clinical development is needed if the drug already has US approval, and the company can self-apply for EMA approval. A commercial partner in the EU is only required for market access. However, the partner may lack the capacity for pharmacovigilance (PV) maintenance. The company may also have a lack of understanding of EU regulations.

  • Building own EU operations

Setting up an EU headquarters and employing its teams is common practice, as companies often seek commercial partners to launch products. However, there may be a lack of capacity to handle life cycle management (LCM) matters, as well as for local support in different regions.

Planning Your International Expansion

Recognising the challenges above for the EU and US markets is key to planning your expansion projects. The following section goes in-depth into these major challenges and identifies how ProductLife Group can support overcoming them through experts with both knowledge and experience. 

Building EU/US Operations and Understanding EU/US Regulations

EU/US Regulatory Intelligence and Strategy

Chinese pharmaceutical companies often lack experience and expertise in navigating the unique regulatory requirements of the EU and US markets, which can cause delays and difficulties in gaining approval, as well as potential fines and legal issues if requirements are not properly met. To address this, PLG offers a Regulatory Intelligence report to help clients understand the regulations governing the market and the procedures, timelines, and costs associated with pre and post-registration. Alternatively, for a specific product and targeted market, PLG can provide a regulatory strategy report with analytical suggestions for the best pathway to successful registration, including timelines and administrative costs. PLG relies on its partners to provide sufficient information when the market focus is a niche. Additionally, PLG offers Marketing Authorisation Application services, including Dossier Preparation, eCTD Publishing and Global Submission Management services to alleviate the burden on clients. We also support project management and technical expertise. 

Entity Set-Up

PLG can assist companies in establishing an office in the EU. Given the excessive costs associated with setting up an entity abroad for registration purposes, we can act as the Marketing Authorization Holder (MAH) for their products. 

Clinical Trials and Bridging Studies for EU and US Registrations

Before registration, having the appropriate data for pre-clinical and clinical data/modules is important. ProductLife Group strongly suggests that clients perform due diligence on the pre-clinical and clinical data to identify gaps. Furthermore, PLG can support filling those gaps with updates or additional study suggestions. PLG’s in-house regulatory medical writing experts also cover a wide range of products and technologies, such as Biologics and innovative technology, such as Liposomal, which shows an increasing trend in today’s global markets.  

We review existing data and identify gaps, then design a development plan, including bridging strategies or additional pre-clinical and clinical studies to fill the gaps. Our expertise covers due diligence and strategy activities for diverse product portfolios, including complex generics, biosimilars, biologics, and NCEs (New Chemical Entity) for major global markets.   

Partnering for Market Access

As healthcare systems continue to evolve and budgets become increasingly constrained, it is crucial to have a clear understanding of a product’s value proposition, potential pricing levels, and reimbursement conditions. ProductLife Consulting provides strategic guidance on market access issues, leveraging our internal expertise, advisory boards, and market research to generate insights.  

We support clients from early clinical development stages to clarify and stress-test their product’s value proposition and estimate potential future pricing and reimbursement conditions in key countries. Throughout the development process, we help clients reassess their strategies and identify critical data to collect for market access purposes. Our approach integrates market access considerations with other product development activities, enabling us to optimise data for market authorisation, pricing, and reimbursement. Our offering includes medicines and innovative therapeutics such as digital therapeutics and medical devices.

GMP Compliance and Inspection Support

Compliance with GMP regulations is essential to ensure regulatory compliance, maintain product quality, and achieve overall success in the pharmaceutical industry. At PLG, we provide services to assist clients in triggering a GMP inspection. We coordinate with the relevant regulatory agency to ensure compliance with their requirements, arrange inspection dates, and make necessary preparations. Furthermore, our experienced auditors can conduct mock audits to help companies prepare for inspections and reduce additional costs. 

Life Cycle Management (LCM) Services

ProductLife Group provides comprehensive support to clients even after their Marketing Authorisation Application is approved. Our services include managing Variations (Type IA, IB, and II), Renewals, Sunset Clauses, MA Transfers, and Article 61.3. In addition, we work closely with regulatory agencies to ensure compliance with all relevant regulations and guidelines. 

Pharmacovigilance (PV) Support for Safety and Compliance

Pharmacovigilance is critical during the registration and post-approval periods of a drug’s life cycle, as it helps ensure the quality, safety and efficacy of the medicines being produced. After exiting the EU, some countries, like the UK, may require a local contact for pharmacovigilance. PLG supports pharmacovigilance services during registration and post-approval periods, including developing pharmacovigilance plans, risk management, adverse event reporting, signal detection, benefit-risk assessment, and regulatory compliance. These services help to monitor, detect, assess, and prevent adverse effects and other drug-related problems. In addition, pharmacovigilance regulations in the EU and US are dynamic and are always being updated. Therefore, it would be pertinent for pharmaceutical companies to keep compliant with these changes to maintain the safety and efficacy of their products.    


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Overcoming Challenges for the Chinese Pharmaceutical Clients: How PLG Solutions Support Client Success