Elevating Global Regulatory Affairs to a Strategic Priority in the Era of Pharma Globalization

A New Era in China’s Biopharmaceutical Sector Is Rapidly Approaching.

According to data from the “White Paper on Chinese Pharmaceutical Companies Going Global,” China’s contribution to global pharmaceutical R&D rose to 4%–8% in 2018, entering the second tier and emerging as a new force in the global pharmaceutical R&D landscape. In 2020, Chinese innovative drugs entered a period of explosive growth in their international expansion, with the number of innovative drugs going global reaching 39 throughout the year. Cross-border transactions between domestic and overseas pharmaceutical companies totaled 271, representing a 300% increase over five years.

Whether Chinese pharmaceutical companies are expanding overseas or foreign enterprises are entering the Chinese market, pharmaceutical firms seeking global reach inevitably require services such as global regulatory strategies, regulatory consulting, clinical development plans, registration pathways, and regulatory negotiations. The importance and necessity of Regulatory Affairs (RA) are becoming increasingly prominent.

Not long ago, we learned thatGlobal Leading Translational and Clinical Development CRO Amador Bioscience Announces Appointment of Dr. Hao Yuwen as Senior Vice President of Global Regulatory Affairs。

What regulatory affairs challenges are pharmaceutical companies facing in their current globalization efforts? How will AMADOR BIOSCIENCE collaborate with these companies to resolve regulatory hurdles? Dr. Yu Wenhao, a regulatory expert with a truly global perspective on drug regulation, shares his insights on the current state of pharmaceutical globalization. VCBeat conducted an exclusive interview with Dr. Yu Wenhao.

Below is the transcript of the conversation between VCBeat and Dr. Yu Wenhao：

(To facilitate smooth reading, VCBeat has made editorial adjustments to the text without altering its original meaning.)

VCBeat: In the five years since China joined the ICH to align with the highest international standards, what do you perceive as the most significant change in China’s pharmaceutical industry?

Dr. Yuwen Hao: The trend toward globalization is becoming increasingly evident. Although globalization was discussed in the past, it is only in recent years that the industry has truly recognized that many enterprises have already put this into action. Not only are biotech companies, representing new technologies and directions, engaging in global expansion, but even large pharmaceutical companies (BioPharma) are going global.

Furthermore, global standards for international communication, compliance, data management, operational protocols, and document submission acceptance are evolving accordingly. However, the most significant trend is the increasingly pronounced globalization of drug development.

VCBeat: Why is it necessary to elevate the priority of global regulatory affairs today? For pharmaceutical companies pursuing international expansion, in what aspects is the value of global regulatory affairs reflected?

Dr. Yuwen Hao: Throughout the lengthy process of new drug development, spanning from research and development and preclinical trials to Investigational New Drug (IND) application and Phase I–III clinical trials, although many key technologies and functional departments are involved,Regulatory Affairs covers the entire drug development process and occupies a core position.。

From a corporate perspective, particularly for companies with strong R&D capabilities, regulatory affairs professionals are involved throughout the entire product lifecycle—from pre-project feasibility studies to obtaining marketing authorization, and further to post-marketing commitment studies and supplemental applications. It is precisely for this reason that the need for regulatory affairs departments/functions has become especially prominent in today’s increasingly globalized landscape.

Regulatory affairs also play a leading and guiding role in the internationalization of pharmaceutical companies.. Many policy changes directly determine whether a drug product and its indications can go global, and how they can do so. Therefore, policy positioning has endowed regulatory affairs with a uniquely critical role.

It is precisely due to the imperative of global expansion, the continuous evolution of policies, and the integration of regulatory affairs throughout the entire chain of new drug development that regulatory affairs should be accorded a higher priority.

VCBeat: What challenges from global regulatory affairs are pharmaceutical companies currently facing in their "internationalization" efforts?

Dr. Yuwen Hao: Over the past two decades, and particularly in recent years, Chinese pharmaceutical companies’ overseas expansion and foreign enterprises’ entry into China have become increasingly frequent, giving rise to many common issues, includingChallenges of Adapting to Policy Changes, Technical Specifications, and Operational Proceduresetc.

First, the greatest challenge lies in accurately understanding the policy environment and making timely tracking and adjustments.. For instance, the outbreak of the global COVID-19 pandemic shifted the focus of new drug registration in the United States and Europe, during which many COVID-19-related products rapidly entered clinical trials and received marketing approval. It is therefore particularly important for companies to leverage this juncture and stay abreast of policy developments to successfully launch their products overseas.

Additionally, there have been changes in policies regarding operational procedures.For instance, regarding eCTD electronic submission policies, the U.S. FDA mandated in 2015 that commercial Investigational New Drug (IND) applications be submitted in eCTD format, while the European Union will mandate compliance with the Clinical Trials Regulation (CTR) process starting next year (2023). These are significant changes; failure to understand them may hinder or delay international expansion, so thorough preparation is essential.

Likewise, foreign products seeking to enter the Chinese market must closely monitor policy shifts in China, particularly given the substantial changes in recent years regarding the classification of new drugs and the formulation of R&D policies. In effect, China has compressed a century of U.S. pharmaceutical development into just three decades. Furthermore, factors such as cultural and linguistic backgrounds must also be taken into account.

VCBeat: What are the critical pitfalls to avoid in drug review and approval processes in international markets?

Dr. Yuwen Hao：Overall, emphasis should be placed on compliance, operational feasibility, and linguistic and cultural considerations.Compliance efforts often follow the principle that “preparedness ensures success, while lack thereof leads to failure”; therefore, during local drug registration and development, it is essential to strictly adhere to local regulations.A single example can illustrate just how significant this “pitfall” truly is.

Products from overseas companies that are manufactured outside the EU but require clinical trial registration in EU countries must comply with the EU Qualified Person (QP) system, which is a mandatory requirement. However, some Chinese pharmaceutical companies, despite having promising product portfolios and indications that address significant unmet needs in the EU market, have delayed their clinical trials by several months simply because they failed to make prior preparations for QP compliance.

Some companies need to conduct Phase I clinical trials in the United States. After completing toxicology studies in China, they submit the data for an Investigational New Drug (IND) application, only to find that the U.S. FDA has very strict formatting requirements for toxicology reports—namely, the Study Data Tabulation Model (SEND). Due to this single non-compliance issue, the company’s IND submission was not accepted. This serves as a painful lesson.

These may seem like minor matters, but for enterprises, they could well meanThe development timeline and approval date for the entire product portfolio will be forced to shift backward. This represents a significant loss for both companies and patients.

VCBeat: What insights did you gain from your experience as a senior FDA reviewer? How have your perspectives and understanding of regulatory registration for new drug development changed before and after holding this position?

Dr. Yuwen Hao: The FDA provided me with an excellent learning opportunity, allowing me to systematically understand the review framework for the entire product development lifecycle. Meanwhile, the ability to observe multiple projects across different areas has helped me gain insights into industry trends and common challenges. Beyond technical reviews, I have also made significant gains in understanding compliance and regulatory strategies.

VCBeat: What are the unique advantages of Amador Bioscience’s global regulatory affairs team?

Dr. Yuwen Hao: AMADOR BIOSCIENCE's regulatory affairs business isLeveraging the company’s team strengths in domestic and international translational medicine, clinical pharmacology, bioanalysis and biomarkers, clinical development, and global regulatory affairs, along with a quality management system that complies with international standards, leverages the team’s extensive experience in liaising with regulatory authorities across various countries to provide global pharmaceutical companies with services including global regulatory strategies, regulatory consulting, clinical development plans, registration pathways, and regulatory negotiations.

AMADOR BIOSCIENCE boasts a first-class management and technical team, as well as state-of-the-art facilities and technologies. We adhere to the principles of respecting science, ensuring compliance, and putting customers first.

The business characteristics of AMADOR BIOSCIENCE also determine that we are a truly globalized team.From team composition to project involvement, AMADOR BIOSCIENCE has maintained a fully globalized approach throughout.。

This represents a significant departure from existing large and mid-sized CROs. AMADOR rarely conducts regional operations in isolation; instead, the vast majority of its projects involve dual filings in China and the U.S., dual filings in China and Europe, or triple filings across China, the U.S., and Europe. Consequently, from the outset, we have required our teams to possess a high degree of internationalization in terms of personnel and technical capabilities, including cross-cultural competence and language proficiency. We will continue to adhere to this model in the future.

Amador Bioscience has established teams in China, the United States, and Europe, and has successfully completed over 210 marketing authorization submissions (NDA, BLA, MAA). Its client base ranges from leading startup biotechnology companies to multinational pharmaceutical enterprises. I also regularly visit our regional offices to communicate with the teams, ensuring the smooth advancement of Amador’s regulatory affairs operations on a global scale.

VCBeat: How will you lead and shape AMADOR BIOSCIENCE’s global regulatory affairs strategy in the future?

Dr. Yuwen Hao: In the short term, our business will focus on the traditional fields of large-molecule and small-molecule drugs, closely following policies and regulations, highlighting AMADOR BIOSCIENCE’s advantages, and assisting and serving enterprises.

In the future, we also aim to expand our team and establish a next-generation CRO regulatory affairs department capable of handling all common dosage forms, routes of administration, and indications. While consolidating our core drug development services, we will gradually broaden our business scope to encompass medical interventions, medical devices, and other related areas.

VCBeat: How do you view the overall challenges currently facing Chinese innovative pharmaceutical companies in their global expansion?

Dr. Yuwen Hao: First,Uneven distribution.A comparison of innovative drug R&D in Europe and the United States reveals a greater focus, with developers steadfastly adhering to their own strategic pathways and persevering even in the face of challenges within a given therapeutic area. As a result, the ecosystem for innovative drugs in these regions is generally robust and healthy. In contrast, China’s sector remains characterized by technological clustering and intense internal competition.

This is further corroborated by the indications. We found that approximately 60% of our clients’ indications are oncology-related. However, in terms of clinical needs, many indications have been severely neglected. For instance, orphan drugs have only begun to attract attention from domestic companies in the past two years.

Another one isLimited Technology and Product Variety. Many domestic biotech startups have relatively narrow technological portfolios, with the entire company focused on developing a single scaffold or its derivatives, which entails significant risk.

Finally, Chinese companies'Talent reserves, quality, and team integrity are generally weak.. Taking regulatory affairs as an example, the work of this function in the vast majority of companies is limited to organizing and submitting documentation, while high-level talent with expertise in global expansion, regulatory communication, liaison, and meeting preparation—particularly in the areas of strategy and tactical planning—is extremely scarce.

VCBeat: How does AMADOR BIOSCIENCE help these pharmaceutical companies address issues in the aforementioned key stages?

Dr. Yuwen Hao: AMADOR BIOSCIENCE can provide, includingCross-border, integrated one-stop solutions encompassing clinical pharmacology, bioanalysis and biomarkers, clinical research, and regulatory affairs.

AMADOR BIOSCIENCE has consistently served as a “translator” and “bridge,” dedicated to helping clients formulate and execute clinical development strategies from preclinical stages through to market approval. By scientifically selecting doses, targets, and patient populations, and adhering to global quality execution standards, we enhance the success rate of new drug development, maximize therapeutic value, assist pharmaceutical companies in bringing novel therapies to market, and meet patient needs.

In the realm of regulatory affairs, AMADOR BIOSCIENCE will address the key pain points faced by Chinese innovative pharmaceutical companies expanding globally. It will focus on helping these companies better understand policies and regulations, avoid potential pitfalls, provide robust operational support, and enhance cross-cultural and linguistic communication.