International Pharmaceutical Regulatory Monitor

Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline. Includes the full text of European Commission Q&A on New Drug Safety Legislation.

Heeding drug industry feedback, the European Medicines Agency (EMA) is reducing the amount of information it will collect from companies under provisions of the 2010 pharmacovigilance law.

Drug sponsors may be able to bring novel and generic drugs to market earlier in the EU and be eligible for damages if states don’t meet deadlines for pricing and reimbursement decisions, under proposed legislation adopted by the European Commission March 1.

The European Chemicals Agency (ECHA) has launched an online inventory of more than 3 million submission records covering more than 90,000 chemical substances.

To bolster the heparin supply chain, drugmakers are encouraged to trace supplies of porcine mucosa — the primary source of crude heparin — back to the slaughterhouse and provide regulators with the data, a new European Medicines Agency (EMA) draft document states.

Relevant endpoints for clinical trials of drugs to treat pulmonary arterial hypertension (PAH) in children are exercise, time to clinical worsening and hemodynamic parameters, according to a European Medicines Agency (EMA) final guideline.

A European Medicines Agency (EMA) revised draft guideline on the use of near infrared spectroscopy by pharmaceutical companies reflects consensus reached during a May 2011 meeting on the need to clarify NIRS lifecycle and postapproval requirements.

The U.S. Food and Drug Administration (FDA) and its EU and Australian counterparts have developed a blueprint for operating joint good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturing facilities, the Australian Therapeutic Goods Administration (TGA) says.

Drug importers thinking about side-stepping Australia’s registration and listing rules should consider the costs to one company that did.

China’s State Food and Drug Administration (SFDA) has launched a four-month nationwide field program aimed at routing out businesses that provide inferior and counterfeit drugs.

Nearly all of the slight increase in funding President Barack Obama is requesting for the U.S. Food and Drug Administration (FDA) in his fiscal 2013 budget would pay for additional China-based inspectors and greatly enhance agency presence in the country to protect the supply chain.

The U.S. Food and Drug Administration (FDA) is looking at ways to review multiple drugs at once as emerging science produces more combination drugs for serious illnesses, FDA Commissioner Margaret Hamburg says.

Drugmakers must keep an eye on several late-March and early-Mary comment deadlines for regulations on good manufacturing practice (GMP), labeling and other issues.

Drug sponsors who outsource development work to Indian contract research organizations (CRO) should not expect original drug discoveries, according to a new study.

A new International Conference on Harmonisation (ICH) report seeks streamlined postmarket safety filings for drugmakers while adding a new feature to highlight products’ benefits.

A new code of ethical business practice adopted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) calls for strict adherence to global regulatory standards, balanced and accurate drug promotions and greater transparency in industry-sponsored clinical trials.