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Generics/General

EMA logo 2 V13F14

Generics applications under review by EMA – 2013 Q2

Generics/General | Posted 05/07/2013

Last update:  6 September 2013

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Southeast Asia V13I20

Southeast Asian generics market to reach US$3.9 billion by 2016

Generics/General | Posted 20/09/2013

Southeast Asia, with its fast-growing, young population and uninsured majority represent a great opportunity for generics in the pharmaceutical industry, according to Rhett Hemedes, Head of OTC Marketing, Great Eastern Drug Co.

User Fee V13H23

FDA increases generic drug user fees in 2014

Generics/General | Posted 23/08/2013

FDA has increased the amount that generics manufacturers will have to pay to register their finished drug formulation (FDF) facilities by more than US$40,000 for 2014 compared to 2013.

India V13C03

Indian generics companies top ANDA approvals

Generics/General | Posted 09/08/2013

Indian generics companies are beating many other countries when it comes to gaining US FDA approval for their generic drugs.

EMA logo 1 V13C15

Generics applications under review by EMA – 2013 Q1

Generics/General | Posted 29/04/2013

Last update:  6 September 2013

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

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Generics applications under review by EMA – 2012 Q4

Generics/General | Posted 18/01/2013

Last update:  6 September 2013

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

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Generics applications under review by EMA

Generics/General | Posted 05/10/2012

Last update:  6 September 2013

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Generic V13C05

Lipitor generics saved UK NHS £350 million in first 12 months

Generics/General | Posted 31/05/2013

Generics of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) saved the UK’s National Health Service (NHS) more than GBP 350 million in the first 12 months following the expiration of Pfizer’s patent exclusivity.

Patent 1 V13E17

The biggest drug patent losses for 2013

Generics/General | Posted 17/05/2013

During 2012–2018 over US$290 billion of sales are at risk from patent expirations.  In fact, in 2013 alone patents will expire on drugs with yearly sales of US$29 billion. Generics are expected to grab 70% of those sales.

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Indian FDA wants to increase use of generics

Generics/General | Posted 03/05/2013

The Commissioner of Indian Food and Drug Administration (FDA) has denied allegations by physicians and pharmacists in India that the bioavailability of generic drugs is doubtful.