International Pharmaceutical Regulatory Monitor
April 2011 | Vol. 39 No. 4 | Full Issue in PDF Format
The U.S. Food and Drug Administration (FDA) is working with the European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) to finalize a permanent pilot program for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredients (APIs) manufacturing facilities.
The European Commission (EC) is launching a public consultation to possibly revise the transparency rules for member states’ decisions on pricing and reimbursement of medicines, which have not been updated since 1989.
Despite the Court of Justice of the EU’s (CJEU) negative opinion on the proposed European and Community Patent Court, drugmakers can still look forward to continued work toward the initiation of an EU-wide unified patent system.
A committee of experts from the European Directorate for the Quality of Medicines & HealthCare (EDQM) has begun its 2011 review of the Council of Europe recommendations on the classification of medicines as regards their supply and supply conditions.
As part of its annual adjustment, the European Medicines Agency (EMA) is increasing fees for applicants and marketing authorization holders by 2.1 percent.
Information on company pipelines and product profiles will now be listed on the European Medicines Agency’s (EMA) register of small and medium-sized enterprises (SMEs).
Sponsors conducting UK clinical trials for medicinal products must adjust to a new notification scheme.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has created a new website detailing company-led recalls for drug products.
Analysts agree China’s recent drug price cuts, which reduced the maximum retail prices for more than 162 products by 21 percent on average, may not be the last price reductions the pharmaceutical industry could face.
Shared concerns were discussed at a recent meeting between representatives from China and Brazil’s pharmaceutical regulatory affairs agencies.
Generic medicines have barely penetrated the Japanese market, but thanks to government initiatives to educate citizens of their efficacy, the generic industry is poised for large expansion through 2013, according to a recent market forecast.
A new task force, initiated by the Union Minister of Health and Family Welfare, will create a long-term strategy to address various issues faced by India’s pharmaceutical industry.
In response to feedback from the pharmaceutical industry, Australia’s Therapeutic Goods Administration (TGA) is issuing a consultation on its revamped proposed mandatory requirements for electronic submission dossiers.
Medicines Australia is urging the government to deliver on its promise to fix the country’s clinical trial regulations after new figures from the Therapeutic Goods Administration (TGA) show the third straight fall in the annual number of new clinical trials in the country.
As part of its ongoing initiative to become more transparent, Australia’s Therapeutic Goods Administration (TGA) has revised its Australian Register of Therapeutic Goods (ARTG) to make it easier to search for approved pharmaceuticals.
Under a new pilot program, NDAs submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) with Quality by Design (QbD) components will undergo parallel review from both regulatory agencies.
Industry is split over legislation that revises Canada’s Access to Medicines Regime (CAMR), which aims to provide domestically produced generic versions of patented drugs for international humanitarian purposes.
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