MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health of UK.The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organizations to improve blood quality and safety.
The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.

ROLES OF MHRA

Operate post-marketing surveillance for reporting
→ Investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
→ Assessment and authorisation of medicinal products for sale and supply in UK.
→ Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
→ Operate a quality surveillance system and sample to test medicines to address quality defects and to monitor the safety and quality of unlicensed of products
→ Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
→ Regulate clinical trials of medicines and medical devices.
→ Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
→ Promote safe use of medicines and devices.
Manage the General Practice Research Database and the British Pharmacopoeia.
→ MHRA hosts and supports a number of expert advisory bodies, including the Commission on Human Medicine which
replaced the Committee on the Safety of Medicines in 2005, and the British Pharmacopoeia Commission.

THE ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY (ABPI)

The ABPI is the UK pharmaceutical industry’s main industry body and lobby group. Members include seventy five companies in the UK producing prescription medicines, supplying more than 90 per cent of the medicines prescribed through the National Health Service (NHS). Membership of the ABPI is open to companies in the UK which supply prescription medicines for human use.
The ABPI justifiably claims to be the leading body in representing the industry’s views to government and decision makers in the UK. Influencing legislation affecting the industry, and creating a beneficial business environment, stand amongst the ABPI’s principal objectives. It is certainly one of the most powerful of all cross industry groups in the UK, enjoying a very favorable relationship with the government.

THERAPEUTIC GOODS ADMINISTRATION (TGA)

The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products.

We carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.Essentially, any product for which therapeutic claims are made must be either listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market, it also assesses the suitability of medicines and medical devices for export from Australia.

The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.

The TGA administers the Therapeutic Goods Act 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

The TGA works with consumers, health professionals, industry and its international counterparts in order to effectively regulate increasingly complex products resulting from rapid scientific developments.

The Therapeutic Goods Administration is a division of the Australian Government Department of Health and Ageing. The TGA’s overall purpose is to protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured, or exported from Australia.Therapeutic goods include medicines, medical devices and human blood, blood products and tissues.At the same time the TGA aims to ensure that the Australian community has access, within a reasonable timeframe, to new therapeutic goods

GOOD MANUFACTURING PRACTICES (GMP) ENSURES QUALITY ASSURANCE, COMPLIANCE AND GOOD PRODUCT DEVELOPMENT WITHIN THE THERAPEUTIC GOODS INDUSTRY.

What is GMP & cGMP?

•Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and

drug products, medical devices, in vivo and in vitro diagnostic products, and foods.

•Usually see “cGMP” – where c = current, to emphasize that the expectations are dynamic.

1941 Initiation of GMP

•Sulfathiaziole tablets contaminated with phenobarbital

•1941 – 300 people died/injured

•FDA to enforce and revise manufacturing and quality control requirements

•1941 – GMP is born

GMP- Worldwide Enforcement

•Good Manufacturing Practices are enforced in the United States by the FDA

•In the United Kingdom by the Medicines and Healthcare Products Regulatory Agency

•GMPs are enforced in Australia by the Therapeutically Goods Administration

•In India by the Ministry of Health, multinational and/or foreign enterprises

•Many underdeveloped countries lack GMPs

OBJECTIVES of PHARMACEUTICAL DEVELOPMENT :

What is the purpose?

From the perspective of a generic manufacturer, the

objective is to develop a product that is:

•of appropriate quality &

•interchangeable with the innovator brand (so we can avoid expensive & time-consuming studies of safety & efficacy)

From the perspective of the manufacturer of a new dosage
form &/or strength (eg a paediatric dosage form), the

objective is to develop a product that is:

•Of appropriate quality, &

•Of appropriate dosage form & strength, &

•Either has been shown to be safe & effective for the claimed indications & patient population or has been shown to pharmacokinetically interchangeable with a brand that has been shown to be safe & effective for the claimed indications & patient population

•However safety & efficacy is outside the scope of this presentation so I will deal only with generics that

contain the same API in the same dosage form & strength as the innovator

Summary and conclusion

The probability of producing a product that is:

-Of high quality
-Stable
-Consistent from batch to batch, &
-Bioequivalent to the innovator

can be significantly improved by employing a planned & systematic approach to product development, & using all the
information that has been published