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Top M&A Pharma Deals in 2019
The year was marked by mergers and acquisitions (M&A) both big and small. Although not comprehensive, here’s a look at some of the top deals for 2019. Bristol-Myers Squibb Buys Celgene The year started off in January whenBristol-Myers Squibb announced plans to acquire Celgene for about $75 billion. Quickly afterwards, the deal hit a snag as one of…
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EAC aims to eliminate duplication of inspections of drug manufacturers
Public consultations on the draft decision of the EAC Council “Amending the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 93”, concerning the issue of recognition of the results of inspections of drug production site during the period of 2020-2025 has begun on the 25th of December 2019. The…
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A modern Center for laboratory testing of drugs and medical products was opened in Kazakhstan
Minister of Health of the Republic of Kazakhstan Yelzhan Birtanov within the “Densaulyq” state program of health development of the Republic of Kazakhstan for 2016-2019 has opened the Center for laboratory testing of drugs and medical devices At the event opening, Yelzhan Birtanov stressed the importance of establishing the Center for Laboratory Testing (CLT) on…
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An international program for the inspection of sterile drug manufacturers is underway
The European Medicines Agency (EMA), together with European and international partners, is launching a pilot program to enhance cooperation in the field of inspections of sterile drug manufacturers for human use. This new initiative is a result of success and experience gained from a similar collaboration within the International Active Pharmaceutical Ingredient Verification Program(API). This…
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Russian Ministry of Health Registered the First Drug in Accordance with EAEU Requirements
The Ministry of Health of the Russian Federation issued the first registration certificate according to the requirements of Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78 “On the Rules for Registration and Expertise of Medicines for Medical Use” for the medicinal product Granisetron (concentrate for solution preparation for…
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Reference pricing significantly reduced medicine prices in Belarus
A pilot project aimed to register the minimal selling price for cancer and cardiovascular diseases drugs in Belarus allowed to reduce prices for individual drugs by 65% According to Decree No. 345 “On the registration of prices for medicines,” maximal selling price are calculated on the basis of reference pricing, considering data on the cost…
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Russia Will only Accept Registration of Drugs in Accordance with EAEU Rules since 2021
The press service of The Ministry of Industry and Trade of the Russian Federation said that there’s a proposition to accept registration dossiers for new medicines only within the framework of the rules of the Eurasian Economic Union since January 1, 2021. Moreover, the national legislation of the countries included in the EAEU will not…
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Russia Can Join PIC/S and Break into New Pharmaceutical Markets
The PIC/S (Pharmaceutical Inspection Co-operation Scheme) committee meeting was held in Japan. The representatives of the Ministry of Industry and Trade of the Russian Federation, FSI State Institute of Drugs and Good Practices and FSBI The information expertise centre on evaluation, accountancy and analysis of the medicinal products for human use circulation of the Federal…
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Russia Made Changes to the Drug Circulation Law
The Ministry of Industry and Trade of the Russian Federation published a notification on the regulation.gov.ru portal on the preparation of a regulatory legal act on amendments to part 3 of article 47 of Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” regarding the import of drugs to the Russian…
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Verkhovna Rada (the Ukrainian Parliament) allowed comparative advertising of medicines
On November 12, 2019, the Verkhovna Rada adopted the draft Law dated August 29, 2019 No. 0953 “To Amend Certain Legislative Acts of Ukraine (regarding the harmonization of legislation in the field of comparative advertising with European Union law)” The draft lifts the ban on comparative advertising of medicines, established by the current version of…
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