The "1+" Mechanism: Accelerating New Drug Registration in Hong Kong – Our Insights

From our perspective, the "1+" mechanism marks a truly significant step forward in Hong Kong's system for regulating medicines. It's specifically designed to speed up how quickly new drugs, including very advanced therapies and vaccines, can get officially registered and approved here. This is a game-changer for Hong Kong drug registration.

What Exactly is the "1+" Mechanism? Our Understanding

So, what is the "1+" mechanism, and how does it work? To our understanding, it's an innovative pathway for drug registration that essentially says:

• It allows new drugs to be registered in Hong Kong if they've already been approved by at least one major, recognized international drug agency. This is a big deal because, traditionally, you might have needed more.
• According to our experience, it really streamlines the whole registration process for new chemical entities – basically, drugs with brand new active ingredients.
• It's broad enough to include very advanced therapies and important vaccines, which is crucial for modern healthcare.
• Its ultimate goal, as we see it, is to get innovative treatments to patients faster, improving patient access to new treatments.

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How It's Been Implemented and What We've Seen So Far

Timeline of Progress

• This mechanism was officially launched in November 2023.
• What's next for the "1+" mechanism? It quickly expanded in November 2024 to cover all new chemical entities, which shows the government's commitment.
• We've observed a continuous effort in optimizing the process and developing clearer guidelines, indicating ongoing refinement.

Current Achievements: A Glimpse of Success

• From our experience, over 80 pharmaceutical companies have already engaged with this new pathway, which is a strong sign of industry interest.
• More than 260 different drug types are currently being considered for approval, showcasing the breadth of new treatments in the pipeline.
• We're excited to see five drugs have already received approval. This includes:
  • A cutting-edge CAR-T therapy for cancer patients, which truly brings advanced treatment options to Hong Kong.
  • According to our understanding, these approved drugs are also being integrated into the Hospital Authority Drug Formulary, meaning they're becoming readily available for public healthcare, which directly impacts Hong Kong healthcare development.

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Benefits and Impact: Why This Matters

For Patients: Faster Access, Better Options

1. Improved Access:
   • This means much faster availability of new treatments, directly benefiting those who need them most.
   • Patients gain access to innovative therapies that might have taken much longer to arrive before.
   • Overall, it enhances healthcare options for everyone in Hong Kong.
2. Cost Benefits:
   • We anticipate increased competition among pharmaceutical companies.
   • This could lead to a potential reduction in drug costs, making treatments more affordable for patients.
   • Ultimately, it contributes to better affordability and sustainability in healthcare.

For the Pharmaceutical Industry: New Doors Opening

1. Market Opportunities:
   • From our perspective, the streamlined registration process is a huge draw.
   • It provides a more straightforward path to access the vibrant Hong Kong market.
   • Crucially, Hong Kong serves as an important gateway to the massive Greater Bay Area market.
2. Development Support:
   • This mechanism actively encourages more investment in research and development (R&D).
   • The simplified approval pathway makes it more attractive for companies to bring their innovations here.
   • It significantly enhances the market potential for novel drugs.

For the Healthcare System: Raising Standards

1. Quality Enhancement:
   • Access to advanced therapies directly improves the quality of care.
   • It broadens the range of effective treatment options available to doctors.
   • Ultimately, it contributes to elevated healthcare standards across the region.
2. Regional Integration:
   • The "1+" mechanism plays a role in fostering Greater Bay Area connectivity in healthcare.
   • It supports cross-border healthcare development, allowing more seamless patient care.
   • This is a significant step towards overall regional healthcare advancement.

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Greater Bay Area Integration: A Key Expansion

One of the most exciting aspects, in our view, is how the "1+" mechanism ties into the broader Greater Bay Area (GBA) healthcare strategy.

Special Drug and Medical Devices Connect Measure: Our View on Cross-Border Access

• This measure is designed to allow Hong Kong-registered drugs to be used in approved hospitals and healthcare institutions within the GBA.
• Why is the GBA important for drug registration? It covers a massive population of 68 million people, representing a huge potential market.
• It effectively provides a "green channel" for approved products, speeding up their availability across the border.
• From our perspective, it greatly facilitates cross-border healthcare delivery, benefiting patients and businesses alike.

Benefits for Pharmaceutical Companies: Expanded Horizons

1. Market Access:
   • This can lead to a "single registration for multiple markets" benefit, which is incredibly efficient.
   • Companies gain access to a vastly expanded patient population beyond just Hong Kong.
   • It truly streamlines the approval process for regional expansion.
2. Development Opportunities:
   • It actively promotes R&D activities within the GBA.
   • Enhances the overall market potential for drugs developed or registered via Hong Kong.
   • Encourages significant regional collaboration in pharmaceutical development.

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Future Developments: What We Expect

Expected Growth: Continued Momentum

• From our perspective, we anticipate increasing interest from the pharmaceutical industry as the benefits become more widely known.
• We expect to see a growing number of drug applications coming through this pathway.
• This will naturally lead to an expanded product portfolio available in Hong Kong.
• Ultimately, it will offer even more enhanced healthcare options for the community.

Ongoing Improvements: Our Observations

• We've noted continuous efforts in process optimization, which is key to long-term success.
• Guideline development is ongoing, ensuring clarity and adapting to new challenges.
• Industry adaptation is crucial, and we've seen companies actively adjusting to this new system.
• Overall, it reflects a commitment to continuous system enhancement, making new drug approval in Hong Kong even more efficient.

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Contact Information

For further information or assistance, we recommend visiting the official websites:

• Pharmacy and Poisons Board
  • Website: www.ppbhk.org.hk
• Drug Office, Department of Health
  • Website: www.drugoffice.gov.hk