How much does it cost to register a drug in Vietnam
VND 5.5 million
4. What are the approximate fees for each authorization
| Authorization type | Fee per application | |
|---|---|---|
| Drugs (new authorization) | VND 5.5 million | (approx. USD 237) |
| Drugs (renewal authorization) | VND 3 million | (approx. USD 130) |
| Medical devices (Class A) | VND 1 million | (approx. USD 43) |
| Medical devices (Class B) | VND 3 million | (approx. USD 130) |
What is the FDA equivalent in Vietnam
The Drug Administration Department of Vietnam (DAV)
What is the name of the regulatory authority in Vietnam
Regulatory Services in Vietnam
All medicinal products to be imported into the region requires approval from the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) while medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW).
How much does it cost to get a drug approved
In an analysis of the drug development costs for 98 companies over a decade, the average cost per drug developed and approved by a single-drug company was $350 million. But for companies that approved between eight and 13 drugs over 10 years, the cost per drug went as high as $5.5 billion.
How much does it cost per approved drug
Only about 12 percent of drugs entering clinical trials are ultimately approved for introduction by the FDA. In recent studies, estimates of the average R&D cost per new drug range from less than $1 billion to more than $2 billion per drug.
What is China’s FDA equivalent
In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).
What is the biggest pharmaceutical company in Vietnam
DHG PHARMACEUTICAL JOINT STOCK COMPANY DHG Pharma
1. DHG PHARMACEUTICAL JOINT STOCK COMPANY. DHG Pharma is the largest pharmaceutical company in Vietnam by revenue.
Who has the highest authority in Vietnam
The President of the Republic (Vietnamese: Chủ tịch nước Việt Nam) is the head of state, elected to a five-year term by the National Assembly, and is limited by the Constitution to a maximum tenure of 3 terms.
Who approves the laws in Vietnam
The National Assembly of Viet Nam is the highest-level representative body of the people. This body has the supreme supervisory power to oversee all government functions and the implementation of the constitution and laws.
Is it expensive to get FDA approved
How Much Does a FDA 510k Approval Cost The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.
How do I get FDA approval for drugs
Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
What is the most expensive drug approved by FDA
$3.5-Million Hemophilia Gene Therapy Is World's Most Expensive Drug. On 22 November, the US Food and Drug Administration (FDA) approved the first gene therapy for the genetic blood-clotting disorder haemophilia B—a one-time treatment that costs US$3.5 million.
Is ISO the same as FDA
First of all, while it might seem like semantics, people often confuse the terminology that is used between FDA and ISO. FDA conducts an inspection whereas ISO conducts an audit. The two are planned and conducted differently and their conduits have different levels of authority. It does matter to know the difference.
What is the difference between FDA and ISO
An obvious difference between the ISO standard and the FDA regulation with respect to general QMS requirements is that the standard requires a more process-based approach, with specific emphasis on outsourced processes. On the other hand, the FDA regulation has more stringent reporting requirements.
What is the richest company in Vietnam
As of November 2022, Vietcombank, also known as the Joint Stock Commercial Bank for Foreign Trade of Vietnam, was the leading company in Vietnam based on market capitalization, with a market capitalization of around 363 trillion Vietnamese dong.
What is the most profitable company in Vietnam
The Vietnam National Petroleum Group (Petrolimex) remains the biggest revenue earner with more than 304 trillion VND. Meanwhile, the Joint Stock Commercial Bank for Foreign Trade of Vietnam (Vietcombank) recorded the most after-tax profit, almost 29.9 trillion VND.
What is Vietnam power rank in the world
The US News & World Report's ranking of the most powerful countries in the world in 2022 has shown that Vietnam ranks 30th with a GDP of 363 billion USD and a population exceeding 98.2 million people. Other Asian countries, the Republic of Korea, Japan and India are also included in the above ranking.
What is the ranking of Vietnam in the world
30th position
Vietnam has been listed among the world's top 30 powerful countries in 2022 by US News & World Report. With a GDP of over 363 billion USD and a population of more than 98.2 million, Vietnam stands at the 30th position in the rankings, only after Singapore (26th position) among the Southeast Asian countries.
Is Vietnam part of Apostille country
Vietnam is not a member of the Hague Apostille Convention and any official document destined for this country will receive a Certificate from the Secretary of State.
Is it easy to get FDA approval
To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.
How long does it take to get FDA approval
The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.
Is it hard to get FDA approval
On average, it takes ten years and hundreds of millions of dollars to get a new medication approved by the FDA. Only about ten percent of potential drugs make it through the rigorous process to become FDA approved.
How many drugs fail FDA approval
1. Why 90% of clinical drug development fails Drug discovery and development is a long, costly, and high-risk process that takes over 10–15 years with an average cost of over $1–2 billion for each new drug to be approved for clinical use1.
Does FDA require ISO
ISO 13485, an internationally accepted standard, specifies the requirements for a QMS, particularly for the medical devices industry. FDA is aligning its requirements to this standard to drive a global convergence of medical device regulatory processes.
Does China have an FDA equivalent
Drugs and medical devices are overseen by the former China Food and Drug Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR).
