The Hub of the Wheel

Pharmaceutical companies' regulatory affairs units are more vital than ever, but, traditionally, they have not been known for their flexibility. Peter Lassoff explains why this image is outdated, and how working more co-operatively with your regulatory department will help to maximize your success in the market place.

 Readability (QRD) Testing of Patinet Information Leaflet (PIL)

Since 2005, marketing authorization holders of medicines are required to have the patient information leafets for their products readability tested. The European Directive 2004/27/EC (a revision of Directive 2001/83/EC) defines it as follows: 'The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use' .

National Medicines Agency of Romania has published country specific requirements for MRP and DCP 

Useful  information abut specific requirements related to Romania are available.

Bulgarian Drugs Agency continues accepting applications for marketing authorizations

As of 1 January 2007 BDA has stoped accepting applications for marketing authorizations, renewed and variations made of medicinal products until Pharmaceuticals and pharmacies serving human Medicine Act (PPSHMA) enters into force.

Bugarian office of Farmavita.Net has confirmed that  BDA continues accepting applications after new Human Medicines Law has bee adopted in Apirl 2007.

HITH: Concept and clinical guidelines

Hospital in the Home (HITH) is the provision of hospital care in the comfort of the persons own home. In this patients are regarded as hospital inpatients and remain under the care of their treating doctor in the hospital, they receive the same treatment that they have been received in a hospital bed. Patients may be able to receive all their hospital care in HITH. Participation in HITH is voluntary - patients and their carers must agree to have their care provided at home. There are no additional charges to patients for being in HITH and it is available to public patients from the 43 participating public hospitals across the state.

eCTD Viewer and Validator

GECCO is a new eCTD Viewer that provides a uniform and consistent view of eCTDs in the different regions. 

New Legislation for Pediatric Medicines

On 23 October 2006, the Council of the European Union approved all the compromise amendments to the proposal for a Regulation on Medicinal Products for Paediatric Use which were agreed at its second Parliamentary reading. The Regulation was officially published on 27 December 2006 and will enter into force on 26 January 2007.

Requirement for GMP audit of  API manufacturer by MAH

The implementation of EU directives 2004/27/EC and 2004/28/EC makes the requirement for marketing authorisation holder (MAH) to ensure that their Active Pharmaceutical Ingredients (API) have been manufactured to GMP.