EU and US Regulatory Update - Tykerb/Tyverb® (lapatinib)

GlaxoSmithKline has submitted regulatory applications in Europe and the US related to Tykerb/ Tyverb (lapatinib) and its use in combination with trastuzumab to treat patients with HER2 (ErbB2)-positive metastatic breast cancer.

Marketing authorization

Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized by granting of a document also called marketing authorization (equivalent: product license). This process is performed within a legislative framework which defines the requirements necessary for application to the concerned (competent) regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria) and the grounds for approval or rejection of the application, and also the circumstances where a marketing authorization already granted may be withdrawn, suspended or revoked.

Scope, Implications of Section 3(d) Of the Indian Patents Act, 1970 (As Amended)

Under Indian patent law, there are certain inventions which are deemed specifically not patentable.

These are identified in Section 3, and the sub-clause of that section which is relevant with respect to the infamous Novartis case pending before the Chennai High Court and now also IPAB [Intellectual Property Appellate Board] is sub-clause (d) of Section 3.

Pharmaceutical abbreviations

1. You should know and be able to use or interpret the BOLD FACED Latin abbreviations and their English meaning. The complete Latin equivalent is not required. This list has been selected from the typical Latin abbreviation listing and represents those abbreviations widely used in veterinary medicine.
2. You should know and be able to use the various terms for weights and measures for the Metric and Apothecaries' systems. For the Apothecaries' system, you need only know the term "grain" and the relationship between "fluid ounces" and "pint".
3. You should be able to interconvert between the systems, those relations that are printed below in bold typeface, using the approximate equivalencies. These conversions are commonly used in veterinary medicine and/or everyday living. 

Guidelines for Good Manufacturing, Laboratory and Clinical Practices (GMP, GLP, GCP)

a.    Who Good Manufacturing Practices (GMP)

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. 

What is meaning of Common Technical Document (CTD)?

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. 

Worlds Major Regulatory Affairs Authorities

1. World Health Organisation (WHO)
2. US Food and Drug Administartion (USFDA) - USA
3. European Medicine Agency (EMEA) - Europe
4. Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
5. Medicines and Healthcare products Regulatory Agency (MHRA)
6. Therapeutic Goods Administration (TGA) – Australia
7. Central Drug Standard Control Organization (CDSCO)- India
8. State Food and Drug Administration (SFDA) - China
9. Health Canada - Canada
10. National Health Surveillance Agency (Anvisa) – Brazil

Counterfeit (Fake) drugs & new technology to identify it in India

Worth over $12bn, the Indian Pharma industry is expected to grow more than four-fold in the coming decade.

But even as global attention is focused on the healthy growth in India, it is threatened by a serious malaise - counterfeiting.

Fake drugs in the system risk not just lives of patients, but also the reputation of drug makers.

Measures to combat counterfeit medicines

At а national level, each country should develop appropriate medicines policy options, legislation, and enforcement strategies in view of its own situation and availability of institutional framework, professional and financial resources. The policies should aim at involving the Government, its agencies, the pharmaceutical industry, drug importers and distributors, the pharmaceutical profession, governmental organizations, public interest groups and consumer groups, etc in efforts to prevent the supply of counterfeit medicines. Measures are often effective when carried out by all concerned working together.

Factors encouraging counterfeiting of drugs

А variety of factors account for why medicines are attractive for counterfeiting. Medicines are high value items in relation to their bulk and the demand for medicines is infinite. Furthermore, for the counterfeiter, ingredient costs can be very low if cheap substitutes are used or if these are omitted altogether, as is often the case. Producing counterfeit drugs may not require building huge infrastructure or facilities. They can be produced in small cottage industries or in backyards or under the shade of а tree. There are also no overhead costs due to quality assurance or meeting Good Manufacturing Practices (GMP) standards, since such standards are never implemented and gross margins are therefore very high.

Novartis receives FDA approval for Arcapta(TM) Neohaler(TM)

Novartis announced that the US Food and Drug Administration (FDA) has approved once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema[1]. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma. 

Regulatory Affairs & Clinical Research jobs top biotech's "must-hire" list

Which jobs are the most sought-after in the biotech world? Clinical development and regulatory affairs jobs, according to two biotech staffing experts: Victor Kleinman, executive vice president and managing director of the Life Sciences practice at DHR International, and Tom Murphy, senior vice president of life science recruitment at Solomon Page Group. Kleinman and Murphy each have 20-plus years of experience helping biotech and pharma companies meet their staffing needs. And both have insider knowledge on how trends in the industry are affecting the hiring demands in biopharma.

Facts and figure of Regulatory Affairs industry job in India

Facts and figure of Regulatory Affairs industry job in India:

1. 120 odd pharma companies operating in India is having established regulatory affairs departments.
2. More than 1000 company is having unstructured Regulatory Affairs working.
3. Team size of RA department varies. Standard mid-size companies having headcount of 5-10 personnel. MNCs are having 20-30 team size.
4. More than 3700 hard-core regulatory affairs professionals are working in regulatory affairs department in India.

What is Drug Master File (DMF)?

Drug Master File (DMF) is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF.

However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. 

RA professional can get employment as

1)    Regulatory Affairs Associates

2)    Regulatory Affairs Assistance

3)    Regulatory Affairs head/ Director

4)    Medical Information Associates

5)    Drug Inspector/Drug Controller/

6)    Drug Safety Specialist/ Regulatory Food Safety Scientist

7)    Quality Operations/Quality Control/Quality Assurance

Industries which Requires Regulatory Affairs Professionals

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products including:

1)       Pharmaceuticals

2)       Medical devices

3)       In vitro diagnostics

4)       Biologics and biotechnology

5)       Nutritional products

6)       Cosmetics

7)       Veterinary products

8)       Local FDA/ US FDA/UK MHRA/EDQM
9)       Ministry of Health/DCGI

8)       Clinical Research Organization/ Contract Research Organization

10)     Pharmaceutical consultancy companies

The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising and post market surveillance.

Career opportunities in Pharma Regulatory affairs

With increased health awareness, advancement in technology & day by day strengthening of national as well as international regulatory standards has compelled all the regulated industries like pharmaceuticals, biotechnology, medical devices, food industry etc. to come up with dedicated regulatory affairs department to comply with standards of such authorities.

Pharmaceutical Regulatory Affairs is indeed one of the emerging area as far as the pharma jobs are considered and there is huge demand in the market for the qualified RA professional.

With the strengthening of regulatory standards and pressure from regulatory authority, today's pharma industry prefers the professionals with good knowledge of regulatory affairs in every department including R & D, Quality assurance,  Production or Marketing etc.

These phases of rapid changes in regulatory standards have created extreme demand of professional regulatory personnel to analyse, handle and maintain regulatory specification in specified by various regulatory authorities.

The regulatory function in healthcare industries plays vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Role of Regulatory Affairs Professionals

Regulatory Affairs Professionals usually have responsibility for the following general areas:

1. Act as a representative of company to the regulatory authorities to comply effectively all the regulatory issue of business.

 
2. Regulatory personnel ensure that their companies comply with all of the regulations and laws pertaining to their business.

3. Directly face with federal, state and local regulatory agencies and personnel on specific issues i.e. US Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency (PMDA), CDSCO (India), Health Canada.

4. To maintain and handle the company regulatory (GMP, GCP, ISO) audit by government authority or other external authority.

5. To prepare and submit dossier for regulatory approval in research and development phases, clinical trials, manufacturing, labelling and advertising and post market surveillance in format specified by guidelines of respective authorities.

6. Advising company on the current regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs.

Natco Pharma files India's first compulsory license plea

Natco Pharma has applied for the country's first compulsory licence to sell a generic version of Bayer's patented medicine, a development whose outcome is expected to determine how global drug makers price their costly drugs in India.

In compulsory licensing, the government allows a generic firm to produce a patented product without the consent of the patent owner. It is one of the flexibilities on patent protection included in the WTO's agreement on intellectual property -TRIPS (trade-related aspects of intellectual property rights) Agreement.

Facts: Indian Pharma Import

S.NO	COUNTRIES	APR 2004- MAR 2005 (RS. CRORES)	APRIL 2005 – MAR 2006 (RS.  CRORES)
1	China P Rp	908.57	1563.53
2	Switzerland	375.44	547.35
3	U S A	298.11	425.32
4	Germany	188.82	276.33
5	Denmark	107.48	174.48