Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022

Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022

Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022

New Pesticide Registration in China: In-depth Analysis of Challenges and the Trend

New pesticide registration in China is applicable for pesticides containing active ingredients that have not yet been approved for registration in China, including new pesticide TC (TK) and new pesticide formulations. The applicant applying for new pesticide registration shall submit the registration applications for both new pesticide TC and new pesticide formulations, as well as reference samples of the pesticide in accordance with the Administrative Measures for the Registration of Pesticides. Since the implementation of the new Pesticide Registration Data Requirements, pesticide registration has become a risk-oriented pesticide safety assessment mode, with increased test data requirements, extended technical assessment period, high registration costs, and with uncertainty in China. It to some extent inhibits the registration of new pesticides, but pesticide enterprises still have internal motivation for new pesticide registration. The Inevitable Trend of New Pesticide Registration 1. Policy orientation On January 29, 2022, the Ministry of Agriculture and Rural Affairs,…

Apr. 18th, 2022

How to Amend a Registered Pesticide Product under US EPA?

As is well known, the US EPA pesticide registration has always been a difficult task for pesticide enterprises. Enterprises usually have to spend a huge amount of cost to complete a pesticide registration under the US EPA, but subject to registration amendments afterwards due to various reasons, such as trade market demands, formula changes, active ingredient source changes, label changes, etc. What’s the difference between the pesticide registration amendments and new registration? Is the registration amendments easier than new registration? In this article, REACH24H will give a detailed introduction to pesticide registration amendments under the US EPA. What is Pesticide Registration Amendment?  Registration amendments are required when any changes in composition, labeling and packaging of registered pesticide products occur. According to the content of the changes, registration amendments can be categorized into three types: amendment application, notification and non-notification. Registration Amendments Amendment Application Fast-track Amendments Do not require data submission…

Apr. 11th, 2022

China Pharmaceutical Regulatory Updates | March 2022

China NMPA Releases the 52nd List of RLDs On March 11, China NMPA released the 52nd List of Reference Listed Drugs (RLDs). The list covers 52 drugs, including Abbott\’s Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets, as well as Merck\’s Bisoprolol Fumarate and Amlodipine Besylate Tablets.1 CDE Consults on Procedures for Adjusting the RLD List On March 11, CDE published the draft of Procedures for Adjusting the Released Reference Listed Drugs for public comments. Up to date, there are 4,849 RLDs in the Catalog of Reference Listed Drugs. The RLDs are selected as reference products to which new generic drugs are compared to demonstrate bioequivalence. However, a RLD may be delisted for any one of the problems: The RLD has been disqualified from marketing authorization or withdrawn from the market due to risks in safety, efficacy, or quality control. The RLD does not comply with the requirements of the current Chinese Pharmacopoeia or the technical review. Its…

Apr. 08th, 2022

Drug Application Fees for FY 2022 in China and the U.S.

In general, drug regulators charge fees from applicants to ensure the review of drug applications proceed efficiently. For drug applicants, the fees are legally bounded for acquiring or extending marketing authorization. This article introduces drug application fees in China and the United States (U.S.), the top two largest markets targeted by pharmaceutical companies. China National Medical Products Administration (NMPA) has been implementing its latest version of drug registration fee standards since July 1, 2020. The standards are expected to remain in effect till its next version comes out. The fees are mainly charged for drug applications. The U.S. Food and Drug Administration (FDA) updates its drug user fees every fiscal year (FY) which starts from Oct. 1 of last year and ends on Sept. 30 (e.g., FY 2022 is Oct. 1, 2021-Sept. 30, 2022). The drug user fees, which are collected from pharmaceutical industry stakeholders, are levied on applications, programs,…

Feb. 16th, 2022

Biogen\’s Rare Disease Drug Gets Access to More Patients in China Due to NRDL

In December 2021, Biogen cut the price of Spinraza (Nusinersen Sodium Injection) from 700,000 yuan per dose to 33,000 yuan per dose. The move was for getting a place in China\’s National Reimbursement Drug List (NRDL). Thanks to the price cut, nearly 30 patients1 across China got administered with Spinraza on Jan. 1, the first day of the new NRDL took effect. Spinraza Entered the Chinese SMA Treatment Market Via Priority Review SMA, a rare disease characterized by muscle atrophy or weakness, currently affects 30,000-50,000 patients in China.2 The disease\’s incidence is 1/10,000-1/6,000 among infants. According to estimation, about 1,023 to 1,705 among the average 10,232,667 newborn babies4 in China during the past three years suffer from SMA. Biogen became the first SMA therapy approved by China National Medical Administration on Feb. 25, 2019, about two years after the approval by the U.S. Food and Drug Administration on Dec. 23, 2016.5. Given Spinraza\’s…

Feb. 16th, 2022

China Greenlights Online Sales of Prescription Drugs in Shenzhen

China officially permits Shenzhen to pilot the online sales of prescription drugs, according to the market-access-relaxing measures released by National Development and Reform Commission and the Ministry of Commerce on Jan. 26. Following the Hainan Free Trade Port, Shenzhen becomes the second place allowed to sell prescription drugs online. Before the pilot programs in Hainan and Shenzhen, no regulations in China have unequivocally allowed the online trade of prescription drugs. However, some provincial governments and third-party e-commerce platforms like Alibaba and JD.com have had a try amid the trend of internet-based diagnosis and treatment in recent years. The online sales of prescription drugs, as an unauthorized activity, has received continuous objections due to public concerns about drug abuse. Therefore, to ensure safety, the pilot measures for Shenzhen only allow prescription drugs to be sold to patients who have the corresponding prescriptions. The prescriptions should come from the Shenzhen Electronic Prescription…

Feb. 16th, 2022

China Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)

On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements on raw materials, technical criteria, testing methods, labeling and instruction of these body-use disinfecting products, which would provide scientific foundations for the quality evaluation, correct product claim and consumer choice and promote the standardization process of China’s antimicrobial industry. Product Scope Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim. Raw Materials and Banned Substances All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as…

Dec. 17th, 2021
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