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Generics applications under review by EMA – 2013 Q4

Last update:  20 January 2014

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 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. 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].

EMA approves first generic imatinib

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib.

Indian pharma industry to get government support

In a bid to promote the manufacture of pharmaceuticals in the country, the Indian Government has announced plans to set up a Rs 500-crore venture capital fund to provide cheaper loans to firms looking to establish or upgrade manufacturing facilities.

Generics applications under review by EMA – April 2015

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 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. 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].

Soaring generics prices come under increased scrutiny

The US Department of Health and Human Services (HHS) is to investigate the soaring prices of generics in the US.

France outlines plans to promote generics

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, in 2012, in order to combat rising healthcare costs, the French Government introduced measures to increase generic drug use in the country [1]. Now the government has gone a step further and is introducing a national action plan to encourage the use of generics in the country.

Dr Reddy’s US drug pricing comes under scrutiny

Dr Reddy’s Laboratories, the India-based generics drugmaker, has been asked to share drug-pricing information with the attorneys general of California and Texas in November 2014. The two US States take their lead from an investigation into generics pricing at the national level.  

Health Canada clamps down on GMP compliance

Canada’s federal health department Health Canada has written to its licensed drug and active pharmaceutical ingredients (API) manufacturers worldwide reminding them of their regulatory responsibilities and obligations. The department plans to step up planned and unplanned inspections of facilities, with the aim of taking timely and appropriate action where needed.

FDA cash to develop hard-to-copy generics

The US Food and Drug Administration (FDA) is offering US$850,000 to research teams working on generics development. Funds will be split between three programmes: bioequivalence testing for long-acting periodontal drugs; developing methods for assessing long-acting injectable generics; and dissolution methods for long-acting levonorgestrel intrauterine system. Funds may be extended for a further two years.

Pfizer warns UK doctors not to prescribe generic Lyrica for pain

Pharma giant Pfizer is fighting hard to protect one of its brand-name products, this time its epilepsy treatment Lyrica (pregabalin).

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