Can Chinese medicine go overseas only to the United States?

When the poor boy Columbus took the three small broken boats that the 18th-tier investors exchanged for the dowry, through 70 days and nights of turbulent waves, he finally boarded the India in his mind
.

He originally intended to leave a hereditary replacement for his grandson, but by chance, he became the breaking point of the millennium dark medieval inflection in Europe, standing in the golden sunshine of history and being remembered by the world

He set off with a letter of credentials to the Chinese monarch, insisting to the death that he had arrived in India, only to discover the American continent
.

The development of history has always caught people off guard, and can't help laughing and crying

But the negative law of negation, which is the basic law of philosophy, tells us that everything in the world is just like that
.

The development of things is not a straight forward but a spiral upward, and every thing has experienced a process of affirmation, negation, negation of negation, or a cycle

The development of things is not a straight forward but a spiral upward, and every thing has experienced a process of affirmation, negation, negation of negation, or a cycle

However, China, which is famous for concentrating its efforts on major events, has not been able to surpass India, which has only 20% of its own GDP per capita, in the field of medicine going overseas
.

Even many Chinese companies will export APIs to India, and then Indian companies will conduct global registration, clinical trials and sales

As a special commodity, drugs are strongly regulated around the world.
As a major chemical country, China is not weak in the field of drug production, and global regulatory registration and clinical trials are the weakest link for Chinese medicine and medicine to go overseas, among which the weakest It is the ability of Chinese pharmaceutical companies to manage MRCT research, which is the relevant content of ICH E17
.

The full name is ICH guideline E17 on general principles for planning and design of multi-regional clinical trials
.

MRCT (multi-regional clinical trials) refers to clinical trials carried out by the same program in multiple regions, where Regional can refer to geographic regions/regions, countries or different regulatory regions
.

MRCT (multi-regional clinical trials) refers to clinical trials carried out by the same program in multiple regions, where Regional can refer to geographic regions/regions, countries or different regulatory regions

For example, for example, mainland China, Taiwan and Hong Kong SAR belong to three different regions.
Due to their differences in disease distribution, clinical operations and regulatory regulations at least, the same treatment method may be completely different.
effect
.

And in this strong difference and background noise, the curative effect is significant, and it will be of extraordinarily clinical value

Generally speaking, intrinsic factors include: disease status distribution, gene polymorphism, liver and kidney function, height, weight,
etc.

In general, intrinsic factors include:

In general, external factors include: climate, language, education, disease definition, treatment methods, clinical practice, standard treatment, patient compliance, and regulatory requirements
.

In general, external factors include:

In my opinion, E17 and multi-regional clinical trials will help us in the following ways for Chinese medicine to go overseas:

E17 and multi-regional clinical trials have the following help for our Chinese medicine to go overseas:

1.
Avoid figuring out what to do in a boat, and promote full advance communication between the sponsor and the regulator to fully assess risks
.

1.
Avoid figuring out what to do in a boat, and promote full advance communication between the sponsor and the regulator to fully assess risks
.

Since China's long-term R&D habit tends to follow up quickly, the design of clinical trials often follows the former's footsteps.
On the one hand, it lacks the inertia of independent thinking
.

And when our medicine goes to the blue ocean and implements MRCT, the enterprise is not faced with a single voice of a regulatory agency

2.
The east side is not bright and the west side is bright, to promote the simultaneous clinical practice in multiple regions, and the simultaneous listing to reduce market risks
.

2.
The east side is not bright and the west side is bright, to promote the simultaneous clinical practice in multiple regions, and the simultaneous listing to reduce market risks
.

The United States is often the first choice for Chinese medicine to go overseas.
It is true that the United States is the largest medical market in the world, but the competition in the field of clinical trials in the United States is also very sufficient
.
At the same time, considering the research and development habits of Chinese companies, it is very likely that when entering the clinical practice in the United States, the track is already crowded, and patient enrollment will be a big problem
.
If we carry out multi-regional clinical trials, we can quickly enroll enough patients in multiple countries and regions, avoid crowded countries, and rapidly advance the progress of clinical projects
.
At the same time, in the countries where clinical trials are conducted, because we have communicated fully with the regulatory agencies at the CTA stage, when we obtain key clinical data for local patients, we can obtain simultaneous rapid marketing in these countries
.

3.
The MRCT data has stronger extrapolation
.

3.
The MRCT data has stronger extrapolation
.

Multi-regional clinical trials are extremely difficult to operate, and all aspects of registration, application, project management, logistics, insurance, and quality control are huge challenges
.
Large differences in intrinsic and extrinsic factors across regions often mask insignificant efficacy data
.
Under such a high-intensity challenge, the demonstrated efficacy is more likely to be recognized by other countries and regulatory agencies that did not participate in this study
.
For example, a treatment that shows consistent efficacy data in Singapore, Vietnam, Nigeria, Germany and Poland is more likely to be accepted by the US FDA

At the same time, are there other countries and regions that we can consider?

At the same time, are there other countries and regions that we can consider?

In addition to the United States and Australia, there are many regions to choose from among the major pharmaceutical markets in the world.
This is also the core concept included in ICH E17.
The extrapolation of clinical trial results in a single market and region is inherently flawed
.
Here we have selected the medical supervision situation of several major countries and regions and shared them for your reference
.

Singapore

Singapore

Singapore is a member of RECP with a total population of 7 million
.

All public hospitals and specialist centres in Singapore have established their own dedicated clinical trial centres to coordinate hospital clinical trials
.
These centers are committed to being supportive departments for investigators and sponsors, providing guidelines and recommendations, archiving study-related documents, and maintaining a database of ongoing trials in hospitals
.
They also train research teams and CRCs and may provide support to the hospital's IRB
.

Clinical trial fees

The cost of conducting an MRCT global multicenter clinical trial in Singapore is approximately 70%-90% of the cost in the United States
.

Clinical Trial Approval Process

CTA approval time: 30 days

Ethical approval time: 45 days

Approval Order: Parallel

Suggested lead time for clinical trial preparation: 4 months

Singapore will refer to when ratifying NDA: Australia, Canada, US, EU, UK

South Korea

South Korea

South Korea is a member of RECP with a total population of 50 million
.

There is a long history of conducting MRCT multinational clinical trials in South Korea, and nearly 80% of clinical trials are MRCT
.
South Korea has a well-developed infrastructure, a large and dense population, an aging population, and good data quality for clinical trials
.
Korea has implemented ICH GCP since 2000

At the same time, the Korean government has invested heavily in clinical trial infrastructure in order to build a world-class clinical trial base, expand clinical trial capabilities, and improve the capabilities of clinical research professionals
.

Clinical Trial Fees The cost of conducting a multinational clinical trial in South Korea is approximately 70%-90% of the cost in the United States
.

Clinical Trial Approval Process

CTA approval time: 30 days

Ethical approval time: 50 days

Approval Order: Parallel

Suggested lead time for clinical trial preparation: 4 months

Korea will refer to when ratifying NDA: Australia, Canada, US, UK, Japan, Germany, Switzerland, Italy

Canada

Canada

Canada's total population of 38 million is mainly concentrated in the southern part of the border with the United States

Canada is globally recognized for the quality and expertise of its clinical researchers, many of whom have achieved global recognition for major medical discoveries and innovations, and their ability to conduct clinical research in complex therapeutic areas with diverse ethnicities
.

A good public health care system is known for its quality of care, but it also presents some enrollment challenges; clinical trials in areas such as cancer, cardiovascular, rheumatology, etc.
often choose Canada
.
Canada's competitiveness in clinical trials is also supported by strong government support for public research infrastructure, including a more than $1 billion investment in health research funding by the Canadian Institutes of Health Research (CIHR).

Clinical trial fees

The cost of conducting a multinational clinical trial in Canada is approximately 90%-110% of the cost in the United States
.

Clinical Trial Approval Process

CTA approval time: 30 days

Ethical approval time: 30 days

Approval Order: Parallel

Suggested lead time for clinical trial preparation: 3 months

Canada references when ratifying NDA: EU, Switzerland, Australia