harmonization and it’s impact theme2

Harmonization and it’s impact

Prepared By : Naila Kanwal

Senior Officer Regulatory Affairs The Searle Company Limited

INTERNATIONAL HARMONIZATIONHARMONIZATIONIt’s the adjustment of differences, inconsistencies among

different measurements, methods, procedures, schedules, specifications, or system brings features into agreement.

The act or state of agreeing and conformance.INTERNATIONAL HARMONIZATION:Definition:

The process of standardizing laws, regulations and practices to facilitate the expansion, fairness and efficiencies of competing in a globalized economy.

INTERNATIONAL HARMONIZATION

Regulatory HarmonizationThe term “regulatory harmonization” can have different

definitions depending on the context of its usage. One definition that is applicable to those efforts CBER is involved with is: the process by which the interpretation and/or application of technical guidelines can be made to be uniform or mutually compatible. The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER:

INTERNATIONAL HARMONIZATION

Pharmaceutical Inspection Cooperation Scheme

In November 2010, FDA became a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), a network created in 1970 to promote cooperation in the field of GMPs among pharmaceutical inspectorates. The organization, which is based in Geneva, facilitates networking among its members (called Participating Authorities), exchanges inspectional information and experiences in the field of GMP and related areas, and trains GMP inspectors. There are currently 39 Participating Authorities in PIC/S which include most EU Member States, Switzerland, South Africa, Australia, Canada, Singapore and others. CBER has a representative on the FDA Steering Committee managing the Agency's interactions with PIC/S and actively participates in the technical group known as the PIC/S Expert Circle on Human Blood, Tissues and Cells.

INTERNATIONAL HARMONIZATION Asia-Pacific Economic Cooperation Life Sciences

Innovation Forum Regulatory Harmonization Steering Committee

The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) is an on-going initiative founded on the idea that life sciences innovation is important in promoting public and economic health improvement. Early on APEC leaders recognized the importance of good regulatory performance in contributing to life sciences innovation and supported the LSIF’s role as an ‘enabler of regulatory harmonization’. APEC leaders promoted the use of existing international standards and best practices across a number of medical product lines and at the same time served as a vehicle to promote prospective harmonization dialogue in the area of advanced therapies. The LSIF supports a strategic, coordinated approach to harmonization activities, and strives to complement rather than duplicate the work of other parties, thereby leveraging respective resources and efforts. To that end, LSIF endorsed the establishment of the APEC Harmonization Center (AHC) as well as a Regulatory Harmonization Steering Committee (RHSC), both which were inaugurated in June 2009. CBER participates with other Agency components in the work of the RHSC.

ORGANIZATION OF HARMONIZATIONICH : INTERNATIONAL CONFERENCE ON

HARMONZATIONThe International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities and pharmaceutical industry experts from Europe, Japan and the United States to discuss scientific and technical aspects of product registration. ICH also includes the participation of Health Canada, the European Free Trade Association (represented by Swiss Medic) and WHO as official Observers. CBER joins the Center for Drugs Evaluation and Research (CDER) as members to the ICH Steering Committee and provides technical representation to the various expert groups that undertake the work of ICH, i.e., Expert Working Groups, Implementation Working Groups, Informal Discussion Groups, Brainstorming Groups, etc.

ORGANIZATION OF HARMONIZATIONICH : INTERNATIONAL CONFERENCE ON HARMONZATION

ICH : Provides prequalification regarding Pharmaceutical manufacturing, quality, safety, Efficacy and Regulatory.

MISSION OF ICH :ICH, the international organization

of harmonization and technical requirements for registration of pharmaceutical products for human use, is unique in bringing together the regulatory authorities & pharmaceutical industries of Europe, Japan and US to discuss scientific and technical aspects of drug registration. ICH mission is to achieve greater harmonization to ensure that safe, effective and high quality medicines are developed and register in a most resource –Efficient manner.

WORLD HEALTH ORGANIZATIONWHO :The WHO’s core functions should

explicitly provide for its work in promoting and maintaining global health security.

The WHO should provide strategic technical assistance to countries in support of its mission as a provider of global public goods. It should not seek to undertake activities that could or should be done better by others – by the host government, with or without support from other agencies.

The WHO should undertake a review of the skills mix and expertise of its staff to ensure that these fit with its core functions and leadership priorities.

INTERNATIONAL HARMONIZATION AND GLOBAL IMPACT

Positive Aspects of harmonization.

Faster ApprovalsAgree on one set of scientific

rules to running clinical trials.Reducing Expenses (In terms of

Research animals and human testing).

Established a set of standards for the manufacturing processes of new drugs.

INTERNATIONAL HARMONISATION AND GLOBAL IMPACT

Ensured similar application process for drug approval in all countries.

Ensured that research findings from one member country will be accepted by all other countries (With some exceptions for special population).

Market drugs faster.Provision of quality drugs with

Efficacy.Trade Battle.


Fair representation : Created detailed guideline on ensuring ethnic representation, geriatric representation and pediatric representation.

Provided safety guideline for clinical trials.

Post marketing safety data is mandatory.

The promise of innovation. Opened the doors of public

consultation.


Drug availability and human rights.

Safe medicines to be produced.Reduced research duplications.Harmonized documentation

procedures.Competitive enhancement of

positions of follower companies worldwide,

Unique project.


Drawbacks of ICH Harmonization:Public accountability is missing.ICH has not addressed the certain

problems of drug regulations.Reduced the safety tests with

respect to trials.Potentially weaken the public

health.ICH is not concerned with drug

safety.Limit Competetion.


Raised the cost of medicine.Threatened the production of

inexpensive generic drugs.

INTERNATIONAL HARMONIZATION AND PHARMACEUTICAL REGULATION IN PAKISTAN.History :• 1972 : Drugs (Generics) Act passed prohibiting use of brand names / differentiation, instituting 100% control on pricing.•1976 : Allowing for use of brand names.•2001 : Price increase granted by the Ministry of Health to manufacturers to allow for inflation, rise in cost of inputs.

INTERNATIONAL HARMONIZATION AND PHARMACEUTICAL REGULATION IN PAKISTAN.History :•2011 : Dissolution of MOH, DRAP formed.•2012 : DRAP Act 2012.(Fake medicine crisis .e.g. Efroze Chemical)•2015 : Medical Devices rule.

INTERNATIONAL HARMONIZATION AND PHARMACEUTICAL REGULATION IN PAKISTAN.•No Price adjustments for inflation.•No policy for OTC.•Poor Domestic regulation.•Weak Govt. Procurement policies. •No Encouragement to invest in Quality.•Energy crisis.•No R & D grants.

INTERNATIONAL HARMONIZATION AND PHARMACEUTICAL REGULATION IN PAKISTAN.•No tax benefits to Pharmaceutical Industry.No Support on utilities.•Lack of capacity to enforce quality standards.•Complete emphasis on Price Control Vs. Quality Control.•Lack of transparency.•Only Production oriented culture.

INTERNATIONAL HARMONIZATION AND PHARMACEUTICAL REGULATION IN PAKISTAN.• No focus on Quality only quantity matters.•Lack of investment for betterment and improvement.• GMP regulations are not followed by Local industry.•Local Pharmaceutical suffer from bad condition, Insufficient resources and lack of decision making is the main reason.•High Tax rate at heavy machinery and equipments.

INTERNATIONAL HARMONIZATION AND PHARMACEUTICAL REGULATION IN PAKISTAN.• To maintain quality is very costly.• Not meet the international GMP requirement.• Poor regulatory standards.•No investment for biotechnology.

Thanks!!!!!!!!!!!!

harmonization and it’s impact theme2

Documents