[Stability Testing related News – vol.3]

◆ The environmental risk-assessment is to be performed during the development of new medicines. (25-Mar-13 EMA)

Environmental risk-assessment of medicinal products for human and veterinary use is the process through which the European Medicines Agency ensures that the potential effects of pharmaceuticals on the environment are studied and adequate precautions taken in case specific risks are identified.

The environmental risk-assessment (ERA) of medicinal products is to be performed by companies during the development of new medicines.
The results are submitted to the European Medicines Agency for evaluation in conjunction with the scientific data on quality, safety and efficacy required to support the request for marketing authorisation of medicinal products intended for human or veterinary use via the centralised procedure.

The outcome of an ERA will serve as the basis
• minimising the amount of medicinal product released into the environment by appropriate measures;
• identification of specific risk-minimisation activities to be taken by the user of the medicine;
• appropriate labelling, to facilitate the correct disposal of the medicinal product by patients/healthcare professionals (e.g. ensure that the medicine is disposed of in special containers or returned to a pharmacy).

◆ The Brazilian monitoring authority ANVISA is also responsible for medical devices. (09-Apr-13 ECA)

The Brazilian monitoring authority ANVISA is also responsible for medical devices. It published a “Resolution” No.59  with GMP requirements for medical devices (“Establish and implement requirements for Good Manufacturing Practice of establishments that manufacture or market medical devices”). These GMP requirements are very similar to those used by the FDA for medical devices (21 CFR 820, Quality System Regulations, QSR). It is interesting to notice that the document contains a part B on “Quality System Requirements”  which is a 8-page check list divided into 4 medical devices classes (low to high risk potential) with regard to the ANVISA GMP requirements. As the Brazilian GMP provisions are very similar to the US American ones, the inspection check list may also be useful for companies who want to export in the USA.
Click here to access the Resolution 59 with the inspection check list.

◆  WHO’s New Draft Guideline on Submission of Quality Data for Generic Medicinal Products (03-Apr-13 ECA)

At the beginning of March, the WHO published a draft document entitled “Guidelines on Submission of Documentation for a multisource (Generic) Finished Pharmaceutical Product: Quality Part”. The document provides recommendations on the submission of quality information for APIs and finished medicinal products with regard to national authorisation procedures for generic medicinal products. The basis for this is the modular structure of the CTD according to ICH M4Q which has been completely taken over by the WHO guideline.

The scope of this guideline encompasses generic medicinal products containing APIs which have been previously approved through a finished product by a regulatory authority which is a member of the ICH or an ICH observer. The guideline doesn’t apply to biological, biotechnological and herbal APIs.
There are several scenarios for generic medicinal products regarding diverse API manufacturers, medicinal product strengths, containers, dosage forms, etc, like for example:

The medicinal product contains several APIs.
The API comes from multiple manufacturers
The medicinal product is manufactured with multiple strengths (e.g. 10, 50, 100 mg)
The medicinal product is manufactured with multiple container closure systems (e.g. bottles and unit dose blisters)
The medicinal product is available in different dosage forms (i.e. tablets and a parenteral product)
The medicinal product is supplied with reconstitution diluents.
The guideline provides concrete recommendation on how to submit information within the CTD structure.

The document ends with an appendix about conducting and assessing comparative dissolution profiles.

The guideline can be commented until 25 April 2013.

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