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Generics applications under review by EMA – December 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].

Proposed rebates will hit patients, not drug companies

Attempts by US Congress to halt the rise in generics prices with new rebates payable by drugmakers has received a stinging rebuff from the Generic Pharmaceutical Association (GPhA).

US politicians form Affordable Drug Pricing Task Force

On 4 November 2015, democratic members of the House Committee on Oversight & Government Reform launched the Affordable Drug Pricing Task Force, which its members say will bring about ‘meaningful action to combat the skyrocketing costs of pharmaceuticals’.

FDA making progress with ANDA backlog

Despite an increase in the volume of abbreviated new drug application (ANDA) submissions, Type II API Drug Master Files (DMFs), supplements and amendments during financial year (FY)2014, the US Food and Drug Administration (FDA) has acted on more pending submissions compared to FY2013.

Brand-name drugmakers gain extra days of patent protection

Brand-name drugmakers have gained some extra time, be it only days, for protection of their originator drugs after a ruling by the Court of Justice of the European Union clarified the date that drug patents expire.

Sun Pharma recalls drugs from troubled Halol plant

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again having to recall drugs from its troubled Halol plant in Gujarat, India.

Generics applications under review by EMA – August 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].

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.

Canada bans imports from three API facilities in India

Just days after Canada’s federal department responsible for health was reported to be in talks with the US Food and Drug Administration (FDA) about Canadian generics maker Apotex, Health Canada has announced that it is to ban imports from two of Apotex’s facilities and from one site belonging to IPCA Laboratories in India.