Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars
Responding to strong desire of overseas and multinational pharmaceutical manufacturers and domestic pharmaceutical manufacturers to carry out research and development of biosimilar products, this is first time in history.
Read More »Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs
This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of CFDAs requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products:China Pharmaceutical Guidebook Series (3)
This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides a detailed introduction of CFDAs requirements for materials and clinical trials of registration application and approval for imported biological products.
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medicines:China Pharmaceutical Guidebook Series (4)
This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the Chinese pharmaceutical authorities requirements for materials and clinical trials of application and approval for imported traditional Chinese medicine.
Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China
Chinas healthcare market is indispensable for overseas and multinational pharmaceutical companies, but Chinese regulations on pharmaceutical clinical trials are undergoing sharp changes.
Read More »Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market
Chinese regulatory authorities ---- China Food and Drug Administration unprecedentedly set a special examination and approval procedures for innovative medical devices since March 1, 2014, which provides a opportunity to speed up overseas innovative medical devices entry into Chinese market, and reduce risk from the registration examination uncertainty and approval delays to eat up your time and energy.
Read More »China Pharmaceutical Guidebook:Latest Chinese Regulations for Imported Drug Registration
In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency.
Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China
Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.
Read More »Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices
Chinas regulatory framework for medical devices is undergoing radical changes. The countrys new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years.
Read More »Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices
Chinas regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. It will bring overseas and multinational in-vitro diagnostic reagent manufacturers the maximum challenges and opportunities.
Read More »Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices
Now, Chinese regulations on medical devices are undergoing earthshaking changes. Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration
Read More »Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world.
Read More »Latest Guide to Chinese Pharmaceutical GMP Regulations
Latest Guide to Chinese Pharmaceutical GMP Regulations provides a comprehensive and thorough knowledge of the Chinese pharmaceutical GMP regulations to guide overseas pharmaceutical companies and multinational pharmaceutical companies.
Read More »Chinas Guidebook for Pharmaceutical Patent Protection
Chinas Guidebook for Pharmaceutical Patent Protection is an essential resource for overseas and multinational pharmaceutical companies to achieve a successful patent protection for their intellectual property in China.
Read More »Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies
This is the first guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the latest Chinese regulations for imported drug registration, and guide overseas pharmaceutical manufacturers and producers to file the application for their imported drugs with the Chinese pharmaceutical authorities.
Latest guidebook for Chinese Drug Recall Regulations (2014 Edition)
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world.
Read More »Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations (2014 Edition)
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world.
Read More »Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014)
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world.
Read More »Latest Guide to Chinese Medical Device GMP Regulations
Latest Guide to Chinese Medical Device GMP Regulations is an essential resource for overseas medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, which provides a detailed guidance of comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.
Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world.
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