Marketing authorization holder three key managers and crisis management in pharmaceutical companies

We analyze the basic situation of Marketing Authorization Holder (MAH) of drugs in China. Mathematical analysis was carried out on the approval time, product category, dosage form, listing permit holder and production unit of 3239 MAH of drugs in China as of July 31, 2019. We found the following results. The approval time for MAH of drugs was concentrated in 2015, mainly based on chemicals, and the dosage forms were mostly tablets and injections. Furthermore, the number of MAH of drugs varies greatly among different provinces, and the number of Hebei, Guangdong, and Jiangsu ranks in the top three. Thirdly, there are time differences, variety types and geographical differences in the MAH of drugs. This is the application for examination and approval after the full implementation of the MAH of drugs system, and the patent and intellectual property protection in the process of entrusted production technology transfer. The research provides reference for enterprise declaration and regulatory approval management after the full implementation of the MAH system in China.

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Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance

Expert Opinion on Drug Safety ◽

10.1080/14740338.2020.1792883 ◽

2020 ◽

Vol 19 (10) ◽

pp. 1357-1366 ◽

Cited By ~ 1

Author(s):

Inyoung Lee ◽

Todd A. Lee ◽

Stephanie Y. Crawford ◽

Ryan D. Kilpatrick ◽

Gregory S. Calip ◽

...

Keyword(s):

Adverse Event ◽

Signal Detection ◽

Marketing Authorization ◽

Support Programs ◽

Patient Support ◽

Marketing Authorization Holder ◽

Authorization Holder

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A Study on the System of Marketing Authorization Holder in China

Proceedings of the 2017 3rd International Conference on Humanities and Social Science Research (ICHSSR 2017) ◽

10.2991/ichssr-17.2017.33 ◽

2017 ◽

Author(s):

Shiyuan Cheng ◽

Yuzhong Luo

Keyword(s):

Marketing Authorization ◽

Marketing Authorization Holder ◽

Authorization Holder

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Use of Hexyon/Hexacima/Hexaxim in preterm infants in Europe

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.1427 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

F Boisnard ◽

F Caracci ◽

N Badzhinerov ◽

P Dhont ◽

B Isnardy ◽

...

Keyword(s):

Preterm Infants ◽

Safety Data ◽

Standard Of Care ◽

European Countries ◽

Marketing Authorization ◽

Haemophilus Influenzae Type ◽

Black Triangle ◽

Susceptibility To Infection ◽

Authorization Holder ◽

Post Marketing

Abstract Background Worldwide 13 million babies born prematurely every year have increased susceptibility to infection and require adequate immunization. Hexavalent vaccines against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b are standard of care in pediatric vaccination and are particularly important for preterm infants. Hexyon® is registered in Europe since April 2013. Methods Considering birth data from official national databases and only countries with periods of exclusive use of Hexyon from 2013-19, we estimated the total number of preterm infants (<37weeks GA) vaccinated with Hexyon. Results Since registration, Hexyon has been used in 23 European countries and exclusively used in the following: Austria, Feb-2017 to present; Belgium, Jul-2014 (Flanders)/Sep-2015 (Overall) to present; Bulgaria, Nov-2014 to Dec-2016; Croatia, Jan-2016 to present; Denmark, Feb-2016 to Apr-2017; Italy, Apr-2016 to present, exclusivity based on Regions; Macedonia, Oct-2015 to present; Norway, Feb-2017 to present; Romania, Apr-2015 to Dec-2017. The estimated total number of preterm infants during these periods of exclusive use is 183 000. Assuming 90% vaccination coverage, ∼164 700 preterm infants received at least 1 dose of this vaccine. From the analysis of the post-marketing safety data available to date, no new risk has been identified in preterm infants. Conclusions Hexyon has become a standard for hexavalent immunization in infants, regardless of the gestational age at birth. More than 90 million doses have been administered worldwide, including the estimated 164 000 preterm infants in the 9 European countries considered here. The EU Marketing Authorization granted in 2013 with no contraindication for use in preterm infants, was renewed in 2018 and the black triangle was removed confirming that the safety of Hexyon is well established. The marketing authorization holder continues to support evidence generation for use in preterm infants. Key messages Hexyon/Hexacima/Hexaxim has become a standard for hexavalent immunization in infants including for preterm infants (<37weeks GA); around 164 000 preterm infants in 9 European countries received it. The safety of Hexyon/Hexacima/Hexaxim is well established, no new risk has been identified in preterm infants from the analysis of the post-marketing safety data available to date.

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The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

The Journal of Law Medicine & Ethics ◽

10.1017/s107311050000749x ◽

2004 ◽

Vol 32 (1) ◽

pp. 181-184

Author(s):

Amy Garrigues

Keyword(s):

Pharmaceutical Companies ◽

Court Decisions ◽

Patent Holder ◽

Trial Court ◽

Court Of Appeals ◽

The Us ◽

Antitrust Laws ◽

Per Se ◽

Appeals Court ◽

Two Sides

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

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