Generics/General

EGA calls for removal of competition and trade barriers for generics

Generics/General | Posted 28/03/2014

The European Generic medicines Association (EGA) is calling on the EU to remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules.

FDA increases oversight of drug safety in India

Generics/General | Posted 21/03/2014

The US Food and Drug Administration (FDA) has created an Office of Pharmaceutical Quality in response to quality concerns at home and abroad, particularly surrounding generic medicines from several Indian manufacturing plants [1].

Brand-name drugs also cut healthcare costs

Generics/General | Posted 14/03/2014

Generics are often given all the praise when it comes to cutting costs for patients and payers, but, according to a piece in Forbes, brand-name drugs also cut healthcare costs.

FDA starts widespread testing of generics

Generics/General | Posted 28/02/2014

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.

Rising generics use triggers increased worldwide regulation

Generics/General | Posted 06/12/2013

The increasing use of lower cost generics is prompting regulators across the globe to introduce stricter regulations focusing on the quality of these products.

South African HCPs told to ‘get their facts straight’ on generics

Generics/General | Posted 08/11/2013

The South African National Association of Pharmaceutical Manufacturers (NAPM) urged healthcare professionals (HCPs) to ‘get their facts straight’ with respect to generics at a special workshop held at the Johannesburg Country Club on 17 October 2013.

Canada-EU trade deal will extend patents for two years

Generics/General | Posted 31/10/2013

On 18 October 2013, Canada and the European Union (EU) reached agreement on a trade deal, which will free the movement of goods, services, investment and labour between the two regions, but has been criticized by generics makers for delaying access to medicines.

Australians pay too much for generics

Generics/General | Posted 11/10/2013

According to the Consumers Health Forum of Australia (CHF), a body which represents healthcare consumers, Australians are paying way too much for their generic drugs.

Generics applications under review by EMA – 2013 Q3

Generics/General | Posted 04/10/2013

Last update: 4 October 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].

Australian generics association releases new code of practice

Generics/General | Posted 04/10/2013

Australia’s Generic Medicines Industry Association (GMiA) announced on 26 September 2013 the release of the draft third edition of the GMiA Code of Practice, which incorporates a number of new amendments.

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 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.

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.

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.

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].

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].

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].