Policies & Legislation

EGA publishes vision for more efficient regulation of generics and biosimilars

Home/Policies & Legislation | Posted 03/12/2010

On 27 October 2010 the European Generic medicines Association (EGA) published its Vision 2015 following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp, Belgium, 26 October 2010. The EGA is calling for changes in the regulatory requirements for generic and biosimilar medicines ‘for the sake of healthcare sustainability’.

EU patents limp forward

Home/Policies & Legislation | Posted 12/11/2010

The Belgian EU Presidency is trying to break the deadlock over proposals for a single EU-wide patent system, which has been blocked for over a decade due to language issues.

UK scraps generic substitution plans

Home/Policies & Legislation | Posted 08/11/2010

The UK government has announced that it will not progress with plans to automatically substitute medications with generic drugs in primary care. Health Minister Lord Howe announced the decision on 14 October 2010, following a public consultation, which showed that many people thought it posed a risk to the safety of patients and could create more work for National Health Service (NHS) staff.

WHO prequalification programme for medicines

Home/Policies & Legislation | Posted 20/10/2010

Today, one third of the world’s population lacks access to essential medicines. In the poorest parts of Africa and Asia this figure rises to a half of the population.

Price cuts, legislation and reforms

Home/Policies & Legislation | Posted 24/09/2010

In an effort to reduce budgets governments across the globe are lining up price cuts in prescription medicines, new legislation to control medicine prices and reforms in the healthcare systems. The question is how will all these changes affect the generic medicines industry and is it just a short-term fix?

Pharmacovigilance legislation moves a step closer

Home/Policies & Legislation | Posted 24/09/2010

In the European Parliament’s plenary session in Strasbourg on 22 September 2010, Members of European Parliaments voted by a huge majority (559 to 7) to adopt new pharmacovigilance legislation. The new EU law should provide better protection for people with medical conditions and make them better informed about the use and any undesirable side effects of medicines.

China set to give a big boost to biologics

Home/Policies & Legislation | Posted 24/09/2010

According to a report in a Chinese newspaper, China is planning to spend more than CNY 10 billion (US$1.5 billion) to support the development of new drugs between 2011 and 2016. Biotechnology was identified as one of seven emerging industries that China will use to spearhead the next big step in its economic development.

Potential pitfalls in entering China's generics market

Home/Policies & Legislation | Posted 31/08/2009

China's fast-growing pharmaceuticals market is proving attractive to many foreign pharmaceutical firms, including those in the generics sector. Such companies need to be aware of potential pitfalls, some of which were outlined in Scrip News by Mr Jason Wang, Senior Business Development Manager at GreenPine (Tianjin) Pharmaceutical Co, a company that specialises in the registration and distribution of imported pharmaceuticals in China.

New Zealand expects big savings with generic quetiapine

Home/Policies & Legislation | Posted 17/09/2010

The New Zealand pharmaceutical management agency, PHARMAC, expects to save NZ$24 million (US$17.1 million) over the next five years following price reductions for certain antipsychotic drugs. The agency intends to use the savings to fund other medicines.

Battle over ‘pay-for-delay’ deals continues

Home/Policies & Legislation | Posted 17/09/2010

The US Federal Trade Commission (FTC) Chairman, Mr Jon Leibowitz, has been arguing for some months now that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save US consumers billions of dollars. However, a new report throws doubt on the figures used to estimate these savings.