PHARMACEUTICAL REGULATION Realistic and effective laws and regulation

   PHARMACEUTICAL REGULATION

 

Realistic and effective laws and
regulation are purely needed for the pharmaceutical industry that includes:

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·     
Pharmaceuticals are more
important to the whole population.

·     
Various parties are
involved: health providers, patients, manufacturers and salespeople.

·     
Due to the lack,
ineffective use of medications may leads to serious consequences such as injury
and severe death.

·     
There is no way to
determine the product quality by the consumers.

·     
Informal controls are
insufficient.

 

Countries are always used to develop new
legislation and regulate the laws. These laws are made under can bring its
various provisions into operation, one by one, as the necessary resources and
experience are acquired.

The
regulatory authority is generally established for Administrative control.

 

ESTABLISHING  EFFECTIVE ADMINISTRATIVE  CONTROL:

Legislation and regulatory administrative
practices must be attuned to available resources, and every kind of opportunity
must be understood and should use the information provided by the regulatory
authorities in other countries.

The major challenge of these regulatory
agencies and organizations around the world is to ensure about the quality, safety
and efficacy of medical devices and medicines, Harmonization of legal protocol linked
to the process of development of the drug, controlling and ensuring compliance
with a legal agreement.

The main role is to ensure and increase
regulatory implementation in non-regulated parts of the world for the people’s
safety residing there.

The present study describes a brief review
of regulated bodies of major developed and developing countries and the scope
and challenges of such regulatory organizations in drug development and
delivery of safe, effective healthcare products to individuals in the
worldwide.

REQUIRED
RESOURCES:

The national regulatory authorities must
have the following resources to increase the safe and effective healthcare
products all over the world which includes:

·     
Political support

·     
Legal power

·     
Human and financial
resources

·     
Independent decision
making

·     
Proper public support

·     
Effective management.

 

Personnel
are
the key resource for making effective pharmaceutical regulation that
discourages the corruption and conflicts of interest. And the pharmacists or
inspectors are selected depends upon the size of the country and degree of
pharmaceutical development as if the organization consist of few educated
individuals.

Computer software now greatly simplifies
many of the administrative tasks of the regulatory agency. Personnel should
have access to the latest scientific and technical information to facilitate
the work.

Financing:

The main aim is to provide the fund to the
regulatory functions. It may be provided from general tax income and from
charges levied on the manufactures, importers, and distributors to cover the
costs bulk of the pharmaceutical control system.

The purpose of finance:

·     
Capital and recurrent
expenditures

·     
Technical programs

·     
Payment for consultants

·     
Payment for patent and
royalties

·     
Payment for Quality
control samples

·     
Publications

·     
Travel for inspection

 

 REGULATORY AFFAIRS:

Regulatory Affairs is engaged with the
advancement of new medicinal items from an early stage, these regulations are
attained by incorporating the standards by planning and presenting the
significant administrative dossiers to the health specialists.

Regulatory Affairs is involved in every
stage of development of a new medicine and in the post-marketing activities
with authorized medicinal products.

The Regulatory affairs division plays a
vital role in the various structure of pharmaceutical department. all things
considered, it is the interphase of medication advancement, assembling,
advertising and clinical research. Remotely it goes about as a key interphase
between the association and the authoritative experts.